Career Openings

Experience Required: 3–8 Years

Department: Regulatory Affairs

Reporting To: Regulatory Operations Manager / Head – Regulatory Affairs

About the Role

We are looking for an experienced and detail-oriented Regulatory Publishing Specialist to support the preparation, compilation, publishing, validation, submission, archiving, and lifecycle management of global regulatory submissions.

The role involves working with eCTD publishing tools such as DocuBridge and Lorenz and ensuring that regulatory submissions comply with applicable requirements of FDA, EMA, ICH, and other global regulatory agencies.

The ideal candidate should have strong technical knowledge of regulatory publishing and submission standards, excellent attention to detail, strong troubleshooting skills, and the ability to coordinate effectively with cross-functional teams to deliver high-quality submissions within defined timelines.

Key Responsibilities

Regulatory Submission Publishing

• Publish initial applications, supplements, variations, annual reports, renewals, responses, and lifecycle maintenance submissions using DocuBridge, Lorenz, or equivalent publishing tools.

• Compile, assemble, and publish regulatory submission packages in accordance with regional and global regulatory requirements.

• Ensure accurate and timely delivery of electronic submissions to regulatory authorities.

• Support the complete lifecycle management of eCTD submissions, including sequences, replacements, amendments, and withdrawals.

• Verify that all submission components are complete and correctly placed before dispatch.

eCTD Compliance & Quality Management

• Ensure regulatory submissions comply with FDA, EMA, ICH, and applicable regional eCTD standards.

• Perform technical validation and quality-control checks before submission.

• Review submission structures, metadata, hyperlinks, bookmarks, file formats, naming conventions, and document placement.

• Identify, investigate, and rectify technical validation errors before submission dispatch.

• Maintain high standards of submission accuracy, consistency, and technical quality.

Submission Planning & Cross-Functional Coordination

• Coordinate with Regulatory Affairs, Medical Writing, CMC, Quality, Clinical, Pharmacovigilance, and other stakeholders to ensure submission readiness.

• Participate in submission planning meetings, project discussions, and milestone reviews.

• Track submission timelines, deliverables, dependencies, and risks.

• Follow up with stakeholders to obtain required documents and information within agreed timelines.

• Proactively identify potential submission delays and recommend appropriate mitigation measures.

Technical Issue Resolution & Operational Support

• Troubleshoot publishing, validation, document-formatting, and submission-related technical issues.

• Collaborate with internal teams, external partners, vendors, and regulatory stakeholders to resolve submission challenges.

• Provide timely operational support during critical submission periods.

• Escalate significant technical or compliance issues to appropriate stakeholders.

• Support the implementation and maintenance of regulatory publishing systems and tools.

Subject Matter Expertise & Knowledge Sharing

• Serve as a Subject Matter Expert (SME) for eCTD publishing tools, submission standards, and regulatory publishing best practices.

• Provide technical guidance and support to internal stakeholders.

• Conduct training sessions on publishing processes, submission requirements, and regulatory systems.

• Develop and maintain training materials, SOPs, work instructions, checklists, and user guides.

• Stay updated on changes in global regulatory submission standards and health authority requirements.

Documentation & Archive Management

• Maintain complete, accurate, and organized electronic submission archives.

• Ensure appropriate version control, lifecycle documentation, and submission tracking.

• Maintain submission records in Document Management Systems or Regulatory Information Management systems.

• Support audit readiness and regulatory inspection preparedness.

• Ensure submission documents and records are maintained in accordance with applicable retention requirements.

Process Mapping & Continuous Improvement

• Create, review, and maintain process maps for regulatory publishing and submission activities.

• Identify opportunities for process standardization, optimization, and automation.

• Support the development and implementation of publishing templates, tools, and quality-control mechanisms.

• Ensure controlled documentation and effective version-management practices.

• Participate in continuous improvement initiatives to enhance submission quality, efficiency, and compliance.

Required Skills & Qualifications

• Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, Biological Sciences, or a related discipline.

• Postgraduate qualification or certification in Regulatory Affairs will be preferred.

• 3–8 years of relevant experience in Regulatory Operations or Regulatory Publishing.

• Hands-on experience with DocuBridge, Lorenz, eValidator, or equivalent regulatory publishing and validation tools.

• Experience in preparing and publishing FDA, EMA, and other global eCTD submissions.

• Experience with initial applications, lifecycle submissions, variations, supplements, annual reports, renewals, and regulatory responses.

• Experience with Document Management Systems or Regulatory Information Management systems will be preferred.

Technical Skills

• eCTD publishing and submission lifecycle management.

• Knowledge of ICH, FDA, EMA, and regional electronic submission standards.

• Hands-on proficiency in DocuBridge, Lorenz, or equivalent publishing tools.

• Experience with submission validation tools such as eValidator.

• Knowledge of PDF preparation, hyperlinking, bookmarking, metadata, and document formatting.

• Proficiency in Microsoft Office applications.

• Working knowledge of Document Management Systems and Regulatory Information Management systems.

Key Competencies

• Strong attention to detail and commitment to quality.

• Effective project coordination and submission-planning skills.

• Strong analytical, problem-solving, and troubleshooting abilities.

• Effective stakeholder communication and collaboration skills.

• Ability to manage multiple submissions and priorities simultaneously.

• Strong time-management skills and deadline orientation.

• Ability to perform effectively during critical submission periods.

• Continuous learning and process-improvement mindset.

• Ability to work independently as well as collaboratively within cross-functional teams.

Job Features

Department: Regulatory Affairs

Experience: 3–8 Years

Role: Regulatory Publishing Specialist

Apply Online

Interested candidates who meet the above requirements are encouraged to apply by submitting their updated CV through the application form.

Email us: Career@ddreg.in

Position: Manager / Assistant Manager – Regulatory Affairs (US)
Location: Gurgaon, Haryana, India (Onsite)

One important point: the JD does not specify a minimum number of years of experience, so I will not invent an experience requirement. It specifies experience in Drug Regulatory Affairs – US markets with hands-on exposure to ANDA, Module 3 CMC, gap analysis, eCTD submissions and regulatory lifecycle management.

1. Website Content

Job Title: Manager / Assistant Manager – Regulatory Affairs (US)

Location: Gurgaon, Haryana, India (Onsite)

Department: Regulatory Affairs

About the Role

We are looking for an experienced professional for the role of Manager / Assistant Manager – Regulatory Affairs (US) with strong expertise in new submissions, regulatory strategy, and lifecycle management for pharmaceutical products.

The ideal candidate should have hands-on experience in handling ANDA, NDA, 505(b)(2), supplements, amendments, and post-approval submissions in compliance with USFDA and ICH guidelines.

The role requires strong knowledge of regulatory documentation, CMC review, and compliance management for regulated markets, along with excellent leadership, project management, and cross-functional coordination skills.

The candidate should be capable of managing multiple projects within strict timelines while ensuring high-quality regulatory deliverables.

Key Responsibilities

• Lead regulatory strategy, submission planning, and execution for US market filings, including ANDA, NDA, 505(b)(2), supplements, and lifecycle management activities.
• Review and approve Module 1–3 CTD/eCTD dossiers, CMC documentation, gap analysis, and regulatory submissions to ensure compliance with USFDA and ICH guidelines.
• Manage end-to-end lifecycle activities including amendments, annual reports, labeling updates, post-approval changes, and deficiency response management.
• Drive cross-functional coordination with R&D, QA, QC, Manufacturing, Packaging, and Analytical teams for timely regulatory deliverables.
• Handle regulatory agency queries, deficiency letters, and technical communications with USFDA within defined timelines.
• Monitor evolving USFDA regulations, regulatory risks, and compliance requirements to ensure proactive regulatory alignment.
• Lead, mentor, and review the performance of regulatory team members to ensure high-quality submissions and operational efficiency.
• Ensure submission readiness, documentation accuracy, regulatory compliance, and on-time execution of all assigned regulatory projects.

Educational Qualification

• M.Pharm / B.Pharm / M.Sc. in Chemistry, Pharmaceutical Chemistry, Biotechnology, or a related discipline.
• Regulatory Affairs certification will be an added advantage.

Required Experience & Technical Exposure

Experience in Drug Regulatory Affairs for US markets, with hands-on exposure to:

• ANDA filings
• Module 3 CMC documentation
• Gap Analysis
• eCTD submissions
• Regulatory lifecycle management

Knowledge & Skills

• Strong knowledge of global pharmaceutical regulatory requirements and submission processes.
• Strong understanding of US regulatory requirements and USFDA submission processes.
• Knowledge of document management systems.
• Proficiency in Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook.
• Strong analytical and technical interpretation skills.
• Excellent written and verbal communication abilities.
• Strong team-oriented and collaborative mindset.
• Ability to manage multiple projects under strict timelines.

Leadership & Behavioural Competencies

• Strong regulatory leadership and project management capabilities.
• Ability to lead and mentor regulatory team members.
• Effective workload planning and technical guidance.
• Strong cross-functional coordination skills.
• Ability to assess regulatory risks and drive process improvements.
• Strong client management and communication capabilities.
• Ability to maintain high-quality regulatory deliverables while working under strict timelines.

Reporting Structure

Reports to: GM of Regulatory Affairs – US

Why Join Us

• Growth Opportunities
• Learning Exposure
• Better Compensation

Success Factors

The successful candidate will demonstrate:

• Ability to lead high-quality US regulatory submissions and lifecycle activities with strong compliance to USFDA regulations, minimal deficiencies, and timely approvals.
• Strong expertise in regulatory strategy, gap analysis, CTD/eCTD dossier review, deficiency management, and cross-functional regulatory leadership.
• Effective team management, mentoring, workload planning, and technical guidance resulting in high first-cycle quality and operational efficiency.
• Strong client management, communication, regulatory risk assessment, and process improvement capabilities ensuring seamless project execution and regulatory excellence.

Location: Gurgaon, Haryana, India (Onsite)

Position:  Sr. Associate – Regulatory Affairs _Food

Role Summary: 

The Sr. Associate – Regulatory Affairs at DDReg Pharma Pvt Ltd will support regulatory strategy, submissions, and compliance for health supplements and nutraceuticals in India. The role demands strong hands-on expertise in FSSAI regulations, filings, and regulator interactions, along with the ability to manage end-to-end regulatory processes for clients.

Job Descriptions

• Manage preparation, compilation, review, and submission of dossiers for FSSAI product approvals, licenses, and registrations.
• Handle FoSCoS portal activities including new applications, renewals, and modifications.
• Respond to regulatory queries, deficiencies, and notices from FSSAI authorities.
• Ensure compliance with FSSAI regulations including Nutraceuticals Regulations and Labelling & Packaging requirements.
• Provide regulatory guidance to internal teams and clients on product classification, claims, and ingredient compliance.
• Build and maintain strong liaison with FSSAI officials and industry stakeholders.
• Support regulatory strategy and intelligence activities for nutraceutical products.
• Maintain documentation and support audits and inspections.

Knowledge, Skills and Abilities

• Strong knowledge of FSSAI regulations and compliance systems.
• Hands-on experience with FoSCoS filings and documentation.
• Proven ability to interface with regulatory authorities and manage filings independently.
• Excellent communication, attention to detail, and stakeholder management skills.

Qualification and Experience 

• Bachelor’s or Master’s degree in Food Technology, Pharmacy, Life Sciences, Nutrition or related field.
• 3–6 years' experience in regulatory affairs within nutraceuticals/health supplements/food/pharma sector.
• Mandatory experience in FSSAI filings and regulatory processes.

Location

Gurgaon, Haryana (INDIA)

Position:  Sr. Associate – Regulatory Affairs (Biologicals & Vaccines)

Role Summary: 

The Sr. Associate – Regulatory Affairs (Biologicals & Vaccines) at DDReg Pharma Pvt Ltd will be responsible for managing regulatory submissions, approvals, and compliance for biological/biosimilar products and vaccines in India. The role requires strong expertise in CDSCO regulations, end-to-end dossier handling, and proactive engagement with regulatory authorities.

Job Descriptions

• Prepare, compile, and submit regulatory dossiers (CTD/eCTD) for biologicals and vaccines to CDSCO.
• Manage applications for clinical trials, import licenses, test licenses, and marketing authorizations.
• Handle filings via SUGAM portal including new submissions, variations, amendments, and renewals.
• Respond to CDSCO queries, deficiencies, and regulatory communications professionally and on time.
• Ensure compliance with applicable guidelines including New Drugs & Clinical Trial Rules (NDCTR) and biologics guidelines.
• Coordinate with internal and client teams for documentation, data requirements, and regulatory strategy.
• Maintain up-to-date knowledge of regulatory changes, circulars, and notifications from CDSCO.
• Support audit readiness and inspection activities.

Knowledge, Skills and Abilities

• Strong knowledge of CDSCO regulations, NDCTR, and biologics regulatory pathways.
• Proficiency in dossier preparation (CTD/eCTD) and SUGAM portal submissions.
• Demonstrated ability to handle regulatory filings independently.
• Strong networking and liaisoning skills with CDSCO authorities.
• Excellent analytical, documentation, and communication skills.
• Ability to work in a fast-paced consulting environment with multiple projects.
• Act as key liaison with CDSCO officials, subject experts, and regulatory consultants.
• Establish and maintain effective professional relationships with regulatory authorities.
• Represent DDReg Pharma in regulatory meetings and discussions with CDSCO.
• Coordinate with industry forums and stakeholders when required.

Qualification and Experience 

• Bachelor’s or master’s degree in pharmacy, Life Sciences, Biotechnology, or related field.
• 3–6 years of regulatory affairs experience in biologicals, vaccines, or pharma industry.
• Hands-on experience with CDSCO submissions and regulatory pathways is mandatory.

Location

Gurgaon, Haryana (INDIA)

Job Descriptions

• CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC
• Development and implementation of regulatory strategies, processes and timelines for grant of ANDAs.
• Prepares and compiles new ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
• Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
• Demonstrate subject matter and area expertise.
• Collaborate with internal and external clients,
• Supporting and enabling effective and efficient communication that results in operational excellence.
• Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.

Education & Experience

• Master’s degree in Pharma
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 to 6 years’) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities

• Excellent technical data interpretation skills
• Excellent interpersonal skills including problem solving
• Excellent oral and written communication skills with strong presentation skills

• Significant knowledge of US Regulations
• Excellent computer skills; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
• Ability and desire to work in a team-oriented environment.
• Excellent written and verbal communication skills

• Highly proficient with Microsoft Word, PowerPoint and Excel.
• Possesses a collaborative, results-driven style.
• Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines

Other requirements

As may be required from time to time – the incumbent may be required to working slots catering to different time zones

Location

Gurgaon, Haryana (INDIA)

Job Title: Assistant Manager – Regulatory Affairs (EU & UK)

Location: Gurgaon, Haryana (India)

Experience: 4–6 Years

Qualification: Master’s Degree in Pharmacy (M.Pharm or equivalent)

Role Overview

We are seeking a proactive and detail-oriented Assistant Manager – Regulatory Affairs to join our Global Regulatory team. The ideal candidate will be responsible for driving CMC documentation, regulatory submissions, and lifecycle management for the EU & UK markets, ensuring compliance with regional and international guidelines.

Key Responsibilities

• Conduct comprehensive CMC reviews of technical documentation for regulatory filings across the EU and UK markets.

• Perform Gap Analysis and Remediation for Module 3 (CMC) sections to ensure submission readiness and alignment with regulatory standards.

• Develop and implement regulatory strategies, processes, and timelines for the preparation and submission of Marketing Authorization (MA) applications.

• Prepare and compile new CTD dossiers, variations, and renewals ensuring full compliance with applicable EMA/MHRA regulatory requirements and internal quality standards.

• Critically review documentation to ensure internal consistency, compliance with regulatory expectations, and support regulatory excellence.

• Collaborate with cross-functional teams including R&D, QA, QC, Manufacturing, and external stakeholders for timely and accurate data collation and submissions.

• Ensure effective and efficient communication across teams to facilitate streamlined project execution and meet submission timelines.

• Maintain high-level knowledge of current country-specific regulations, keeping track of regulatory updates through respective health authority websites (e.g., EMA, MHRA).

Education & Experience

• Master’s degree in Pharmacy or equivalent qualification.

• 4 to 6 years of relevant experience in Regulatory Affairs, with a focus on EU and/or UK submissions.

• Equivalent combinations of education, training, and practical experience may also be considered.

Key Skills & Competencies

• Strong technical skills in data analysis and interpretation of regulatory documentation.

• Excellent interpersonal and problem-solving skills with a proactive and solution-oriented approach.

• Effective negotiation and communication skills for liaising with internal teams and external agencies.

• Proficient in drafting and reviewing documents in line with global, regional, and national regulatory standards.

• Expertise in document management systems and tools like Excel, Outlook, PowerPoint, and Word.

• Strong presentation and reporting skills with the ability to explain complex regulatory concepts clearly.

• Demonstrated ability to analyze data systematically, apply regulatory logic, and compile well-organized submissions.

• Collaborative, results-driven, and self-motivated with the flexibility to adapt to shifting priorities.

• Capable of delivering high-quality outputs under pressure and within aggressive timelines.

Other Requirements

• Flexibility to work in cross-time-zone schedules, as needed to support global project coordination or agency interactions.

Why Join Us?

Be part of a high-performing regulatory team that plays a critical role in bringing impactful pharmaceutical products to patients globally. Work in a collaborative, fast-paced environment where your expertise shapes international market access strategies.

Job Descriptions

• CMC review of technical documentation for regulatory filings to various markets.

• Development and implementation of regulatory strategies, processes and timelines for grant of MA- Africas, GCC, LATAM, ASEAN.
• Review of CTD dossiers , variations, change controls, renewals and ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
• Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
• Demonstrate subject matter and area expertise.
• Collaborate with internal and external clients,
• Supporting and enabling effective and efficient communication that results in operational excellence.
• Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.

Education & Experience

• Master’s degree in Pharma
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 7 to 10 years’) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities

• Excellent technical data interpretation skills
• Excellent interpersonal skills including problem solving
• Excellent oral and written communication skills with strong presentation skills
• Significant knowledge of US Regulations
• Excellent computer skills; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
• Ability and desire to work in a team-oriented environment.
• Excellent written and verbal communication skills
• Highly proficient with Microsoft Word, PowerPoint and Excel.
• Possesses a collaborative, results-driven style.
• Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines

Other requirements

As may be required from time to time – the incumbent may be required to working slots catering to different time zones

Location

Gurgaon, Haryana (INDIA)

Job Purpose:

DDReg Pharma Pvt Ltd is seeking an experienced Regulatory Affairs Medical Writer responsible for drafting, reviewing, and ensuring the accuracy of scientific and regulatory documents in alignment with global standards. The role involves preparation of complex CTD modules, quality control of submissions, gap analysis, and support in responding to regulatory queries. The ideal candidate will collaborate cross-functionally and support team development and process improvement.

Key Responsibilities:

•  Authoring & Review of Regulatory Documents
  •Draft high-quality medical and regulatory documents in accordance with global guidelines.
  •Prepare complex regulatory documents such as:
       -- Module 2 components (Quality Overall Summary / Nonclinical Overview / Clinical Overview)
        --Regulatory strategy reports
  •Ensure consistency, scientific accuracy, and regulatory compliance across documents.
• Quality Control (QC) of Documents
  •Perform QC review of simple and complex documents including:
         --SPC, PI, PIL, RMP
         --Compiled modules for small molecules and biosimilars
         --SPL, BE templates, TIF
         --Aggregate reports, Expert reports
  •Ensure documents are delivered with high quality and within agreed timelines.
• Gap Analysis
  •Perform gap assessment for small molecules and biosimilar products.
  •Evaluate non-clinical and clinical data provided by clients to identify deficiencies affecting product submission/approval.
  •Draft structured gap reports/sheets and propose corrective actions.
• Query Response & Literature Support
  •Support regulatory query responses by evaluating existing documents and addressing authority/client questions.
  •Conduct literature searches to update documentation and prepare query response reports as required.
  •Work with cross-functional teams to ensure clarity and customer satisfaction.
•  Mentoring & Training
  •Support resolution of technical/medical doubts raised by team members.
  •Provide on-the-job training and guidance to direct reportees.
  •Identify training needs for self and team on a quarterly basis.

Key Skills & Requirements:

• Bachelor’s/Master’s/PhD in Life Sciences, Pharmacy, Biotechnology, or related field.
• 7–10 years of experience in regulatory/medical writing.
• Strong understanding of CTD format and global regulatory guidelines (ICH, FDA, EMA, CDSCO).
• Hands-on experience in:
      --Module 2 documents
      --Data analysis for gap assessment
      --QC of regulatory deliverables
• Excellent written communication, analytical skills, and attention to detail.
• Proficiency in MS Office and documentation systems.

Why Join Us

• Opportunity to contribute to key regulatory submissions
• Exposure to global health authority expectations
• Skill development and continuous learning environment
• Collaborative work culture

Job Descriptions

• CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC
• Development and implementation of regulatory strategies, processes and timelines for grant of ANDAs.
• Prepares and compiles new ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
• Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
• Demonstrate subject matter and area expertise.
• Collaborate with internal and external clients,
• Supporting and enabling effective and efficient communication that results in operational excellence.
• Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.

Education & Experience

• Master’s degree in Pharma
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 to 6 years’) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities

• Excellent technical data interpretation skills
• Excellent interpersonal skills including problem solving
• Excellent oral and written communication skills with strong presentation skills

• Significant knowledge of US Regulations
• Excellent computer skills; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
• Ability and desire to work in a team-oriented environment.
• Excellent written and verbal communication skills

• Highly proficient with Microsoft Word, PowerPoint and Excel.
• Possesses a collaborative, results-driven style.
• Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines

Other requirements

As may be required from time to time – the incumbent may be required to working slots catering to different time zones

Location

Gurgaon, Haryana (INDIA)