Career Openings

Location: Gurgaon, India
Work Mode: Office-Based
Experience: 3–6 Years

DDReg Pharma is looking for an experienced Regulatory Affairs professional with expertise in biologicals and vaccines to join our team.

Key Responsibilities:

• Prepare and submit CTD/eCTD regulatory dossiers to CDSCO.

• Manage clinical trial applications, licenses, marketing authorizations, variations, and renewals.

• Handle SUGAM portal submissions and regulatory queries.

• Ensure compliance with applicable CDSCO regulations, NDCTR, and biologics guidelines.

• Coordinate with clients, internal teams, and regulatory authorities.

Requirements:

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

• 3–6 years of relevant regulatory affairs experience.

• Hands-on experience with CDSCO submissions, CTD/eCTD dossiers, and the SUGAM portal.

• Strong regulatory documentation, communication, and stakeholder management skills.

Interested? Join DDReg Pharma and contribute to regulatory excellence in biologicals and vaccines.

Apply now through our careers page or contact us to learn more.

Join DDReg Pharma and contribute to regulatory projects supporting pharmaceutical products across diverse global markets.

Or you can share your CV directly at career@ddreg.in

Department: Regulatory Affairs
Location: Gurgaon
Reports To: Head – Regulatory Affairs / Director – Regulatory Affairs

Job Purpose

The Senior Associate – Assistant Manager / Regulatory Affairs (Emerging Markets) will be responsible for managing regulatory submissions, approvals, and lifecycle management activities across Emerging Markets, including Asia-Pacific, ASEAN, LATAM, CIS, Middle East, Africa, and other global markets.

The role requires expertise in dossier preparation, product registrations, regulatory compliance, regulatory agency liaison, and cross-functional coordination to ensure timely approvals and uninterrupted business operations.

Key Responsibilities

Regulatory Strategy & Compliance

• Develop and execute regulatory strategies for product registrations, renewals, variations, and line extensions across Emerging Markets.
• Ensure compliance with country-specific regulatory requirements, guidelines, and pharmaceutical regulations.
• Assess regulatory risks and recommend mitigation plans for successful registrations and product launches.
• Monitor regulatory changes and communicate their impact to internal stakeholders.

Product Registration & Lifecycle Management

• Prepare, review, compile, and submit registration dossiers in CTD/eCTD and country-specific formats.
• Manage lifecycle activities including:
  
  • Variations/Amendments
  • Renewals
  • Site Transfers
  • MAH Transfers
  • Labeling Changes
  • Product Withdrawals
• Coordinate timely approvals to support commercial and supply chain objectives.
• Maintain registration status and approval trackers for assigned markets.

Dossier Preparation & Submission Management

• Coordinate with CMC, Quality Assurance, Manufacturing, Clinical, Pharmacovigilance, and Supply Chain teams to obtain regulatory documentation.
• Review Module 1 and country-specific submission requirements.
• Ensure completeness and quality of dossiers before submission.
• Support electronic submissions wherever applicable.

Regulatory Agency Interaction

• Act as the primary contact for local regulatory authorities, distributors, and regulatory consultants.
• Coordinate responses to agency queries, deficiency letters, and information requests.
• Ensure timely closure of regulatory commitments and approvals.
• Support inspections, audits, and regulatory meetings when required.

Labeling & Artwork Management

• Review and approve product labeling, package inserts, artworks, and promotional materials as per local market requirements.
• Coordinate implementation of approved labeling changes with internal and external stakeholders.
• Ensure compliance with local language and country-specific labeling regulations.

Why Join DDReg Pharma?

Growth Opportunities
Global Regulatory Exposure
Learning & Development
Cross-functional Collaboration

Join DDReg Pharma and contribute to regulatory projects supporting pharmaceutical products across diverse global markets.

Or you can share your CV directly at career@ddreg.in

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)