Job Title: Assistant Manager – Regulatory Affairs (Canada Market)

Experience Required: Minimum 3 Years

Location: Gurgaon, Haryana (India)

Department: Regulatory Affairs

Number of Openings: 1

About the Role:

We are seeking an experienced Assistant Manager – Regulatory Affairs to support regulatory submissions and lifecycle management activities for the Canada market. The ideal candidate should have strong knowledge of Health Canada regulatory requirements, dossier review, regulatory strategy, labeling compliance, electronic submission formats, regulatory publishing, and regulatory document management.

The role will involve working closely with cross-functional teams to ensure regulatory submissions are accurate, technically compliant, and completed within defined timelines.

Key Responsibilities:

Regulatory Strategy & Module 1 Review

• Review Module 1 documents for completeness, accuracy, and compliance with Health Canada requirements.

• Develop and review regulatory filing strategies for new registrations, variations, responses, and lifecycle management activities.

• Ensure dossiers meet country-specific regulatory requirements prior to submission.

• Coordinate with cross-functional teams to obtain required documentation and information.

Labeling & Artwork Compliance Review

• Review product labeling, packaging components, and artwork for regulatory compliance.

• Ensure consistency between approved product information, dossier content, and packaging materials.

• Provide timely regulatory feedback to internal stakeholders and clients.

• Identify and mitigate labeling risks before submission or commercialization.

Regulatory Documentation & Archival Management

• Maintain regulatory correspondence, submission records, approvals, and project documentation.

• Ensure accurate and timely archival of regulatory documents in electronic repositories.

• Update project trackers, submission logs, and regulatory databases.

• Prepare periodic regulatory archival and compliance reports.

Process Excellence & Documentation

• Prepare and maintain process maps, SOPs, work instructions, and regulatory guidance documents.

• Support continuous improvement initiatives within the Regulatory Affairs function.

• Ensure regulatory processes remain aligned with organizational quality standards and evolving regulatory requirements.

Electronic Dossier Validation – NeeS/eCTD

• Validate NeeS and country-specific electronic submissions for structural and technical compliance.

• Perform quality checks on hyperlinks, bookmarks, document naming conventions, and navigation functionality.

• Ensure submission packages are technically compliant before dispatch to Health Authorities.

Regulatory Publishing & Submission Readiness

• Review published regulatory dossiers and submission outputs.

• Ensure submission packages meet Health Canada technical requirements.

• Coordinate with publishing teams to achieve submission readiness within agreed timelines.

• Support troubleshooting of publishing and technical submission issues.

Required Skills & Qualifications:

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, or a related scientific discipline.

• Minimum 3 years of experience in Regulatory Affairs.

• Experience in Regulatory Affairs activities related to the Canada market.

• Experience in dossier preparation and review.

• Knowledge of regulatory submissions and lifecycle management activities.

• Hands-on experience with NeeS/eCTD submissions and regulatory publishing.

• Strong understanding of Health Canada regulations and guidance documents.

• Knowledge of regulatory strategy and dossier review.

• Understanding of labeling and artwork compliance requirements.

• Excellent documentation and regulatory record management skills.

• Strong attention to detail and a quality-oriented mindset.

• Excellent communication and stakeholder management skills.

• Ability to manage multiple projects and meet tight regulatory timelines.

Key Skills:

• Regulatory Affairs – Canada

• Health Canada Regulations

• Regulatory Strategy

• Dossier Review

• Module 1 Review

• Regulatory Submissions

• Lifecycle Management

• Labeling & Artwork Compliance

• NeeS / eCTD

• Regulatory Publishing

• Submission Readiness

• Regulatory Documentation

• Stakeholder Management

• Quality & Compliance

Why Join Us:

• Opportunity to work on Regulatory Affairs activities for the Canadian market.

• Exposure to Health Canada regulatory requirements and submission processes.

• Opportunity to work on dossier review, lifecycle management, labeling, and electronic submissions.

• Work with cross-functional teams on regulatory projects.

• Opportunity for professional development and career growth within Regulatory Affairs.

Apply

Interested candidates who meet the above requirements are encouraged to apply.

Minimum Experience Required: 3 Years

Location: Gurgaon, Haryana (India)

Apply via: career.ddreg.in

Job Title: RA Trainee

Experience Required: Fresher / 0–1 Year

Location: Gurgaon

Number of Openings: 3

About the Role:

We are looking for motivated and detail-oriented candidates to join DDReg Pharma as RA Trainees. This role provides an opportunity for freshers to build their career in the Regulatory Affairs domain while gaining practical exposure to regulatory documentation, submissions, dossier preparation, and regulatory guidelines.

Key Responsibilities:

• Assist in the preparation and compilation of regulatory documents.

• Support the team in regulatory submissions and dossier preparation.

• Review regulatory documents for accuracy and completeness.

• Conduct basic regulatory research and review applicable regulatory guidelines.

• Maintain regulatory trackers and records.

• Coordinate with internal teams to obtain the required documents and information.

• Complete assigned tasks within defined timelines.

• Support the team in maintaining accurate and organized regulatory documentation.

Required Skills & Qualifications:

• B.Pharm, M.Pharm, Pharm.D, or relevant qualification.

• Freshers with good knowledge of Regulatory Affairs are encouraged to apply.

• Good understanding of Regulatory Affairs processes and documentation.

• Good written and verbal communication skills.

• Strong documentation skills and attention to detail.

• Basic knowledge of MS Office.

• Willingness to learn and develop within the Regulatory Affairs domain.

• Ability to coordinate effectively with internal teams.

• Ability to manage assigned tasks and meet defined timelines.

Key Skills:

• Regulatory Affairs

• Dossier Preparation

• Regulatory Submissions

• Regulatory Documentation

• Regulatory Guidelines

• MS Office

• Communication Skills

• Attention to Detail

Why Join Us:

• Opportunity to start your career in the Regulatory Affairs domain.

• Gain practical exposure to regulatory documentation and submissions.

• Work alongside experienced professionals in the pharmaceutical industry.

• Develop knowledge of regulatory guidelines and industry practices.

• Opportunity for professional learning and career growth.

Job Title: Sr. SDE -Full Stack Developer (MERN Stack)

Experience Required: 4+ Years

Location: Gurgaon (Onsite) 

About the Role:

We are seeking an experienced Full Stack Developer with a strong command of the MERN stack (MongoDB, Express.js, React.js, Node.js) to join our engineering team. The ideal candidate should have hands-on experience in building scalable web applications, with additional proficiency in TypeScript and Next.js.

Key Responsibilities:

• Design, develop, and maintain high-quality, scalable applications using the MERN stack.
• Write clean, efficient, and modular code following best development practices.
• Implement frontend applications using React.js and Next.js with TypeScript.
• Build responsive and optimized UI components; familiarity with Tailwind CSS is preferred.
• Collaborate on system design and database architecture (SQL & NoSQL).
• Work with Python-based scripts or services for automation or backend integrations.
• Configure and manage CI/CD pipelines to streamline deployment workflows.
• Set up, deploy, and maintain applications on Ubuntu servers, including Nginx configuration and optimization.
• Utilize AWS services (EC2, S3, RDS, etc.) for application hosting and scalability.
• Participate in code reviews, provide technical mentorship, and contribute to architectural decisions.

Required Skills & Qualifications:

• Bachelor’s degree in Computer Science, Engineering, or a related field (or equivalent experience).
• 4+ years of professional experience as a Full Stack Developer.
• Strong expertise in MERN stack (MongoDB, Express.js, React.js, Node.js).
• Proficiency in TypeScript and experience with Next.js.
• Familiarity with Tailwind CSS or other modern UI frameworks.
• Understanding of system and database design principles.
• Experience with CI/CD setup, Git-based version control, and automated deployment workflows.
• Knowledge of Ubuntu/Linux server management and Nginx configuration.
• Exposure to AWS infrastructure for deployment and scalability.
• Excellent problem-solving, debugging, and analytical skills.

Preferred (Nice-to-Have):

• Working knowledge of Python for backend scripting or automation.
• Experience with Docker or Kubernetes for containerized deployments.
• Familiarity with monitoring tools (Grafana, Prometheus, ELK).
• Prior experience mentoring junior developers or leading small teams.

Why Join Us:

• Opportunity to work on modern, scalable, full-stack applications.
• Exposure to advanced web technologies and cloud infrastructure.
• Collaborative, fast-paced, and innovation-driven culture.
• Competitive compensation and career growth opportunities.

Job Descriptions

• Support the drafting of basic medical and regulatory documents such as Prescribing Information (PI), biowaiver justifications, clinical and non-clinical overviews, Structured Product Labeling (SPL), bioequivalence (BE) templates, Technical Information Files (TIF), and supporting regulatory documents under senior guidance.
• Assist in reviewing source documents, clinical and non-clinical study reports, and published scientific literature to extract relevant information for regulatory submissions.
• Perform preliminary quality checks on regulatory and medical writing documents to ensure accuracy, formatting consistency, and alignment with regulatory guidelines.
• Support gap analysis activities for small molecules and biosimilars by identifying missing or unclear information in clinical and non-clinical datasets.
• Assist in preparing draft responses to regulatory or client queries, including updating documents based on feedback and review comments.
• Participate in literature searches and reference management to support medical and regulatory documentation.
• Learn and apply global regulatory guidelines and document standards relevant to medical writing.
• Support project tracking activities by maintaining documentation, version control, and work trackers.
• Communicate progress and challenges effectively with team members and supervisors.
• Demonstrate a proactive learning attitude, attention to detail, and willingness to adapt to evolving regulatory requirements.

Education

• Master’s degree in pharmacology (M.Pharm - Pharmacology) Only.

Knowledge, Skills and Abilities

• Proficiency in Microsoft Word, Excel, and PowerPoint
• Excellent written and spoken English
• Result-oriented and deadline-driven approach

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)

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)