Role & responsibilities

Manager Regulatory Affairs (ROW Formulation)

Department: Regulatory Affairs

Key Responsibilities

Regulatory Strategy & Submission Management

- Develop and execute regulatory strategies for formulation products across assigned ROW markets.
- Evaluate country-specific regulatory requirements and advise project teams on submission strategies.
- Plan and coordinate preparation and submission of registration dossiers, variations, renewals and post-approval submissions.
- Review regulatory submission requirements and identify documentation gaps at an early stage.
- Ensure submissions are prepared and filed within agreed timelines.
- Coordinate regulatory activities from product development through registration and post-approval lifecycle.

Dossier Preparation & Review

- Review and coordinate preparation of regulatory dossiers in applicable formats, including CTD/eCTD or country-specific formats, as required.
- Review CMC documentation related to formulation development, manufacturing processes, specifications, analytical methods, stability data and packaging materials.
- Coordinate collection and compilation of documents from R&D;, QA, QC, Manufacturing and other relevant functions.
- Ensure consistency, accuracy and completeness of information across regulatory dossiers.
- Review artwork, labeling, package inserts and product information documents according to country requirements.

Regulatory Authority Interactions

- Coordinate responses to regulatory authority queries, deficiency letters and assessment reports.
- Prepare, review and coordinate timely responses to regulatory questions with cross-functional stakeholders.
- Support regulatory meetings,



teleconferences and other interactions with health authorities, where applicable.
- Track regulatory commitments and ensure timely implementation and closure.

ROW Market Regulatory Activities

- Maintain working knowledge of regulatory requirements for assigned ROW countries/regions.
- Monitor changes in regulatory guidelines and assess their impact on existing and pipeline products.
- Provide regulatory guidance to business and technical teams for new product registrations and lifecycle activities.
- Support country-specific registration, renewal, variation and compliance activities.

Post-Approval & Lifecycle Management

- Manage regulatory submissions related to:
- Variations / post-approval changes

- Renewals

- Manufacturing site changes

- Process and formulation changes
- Specifications and analytical method changes

- Packaging changes
- Shelf-life/stability updates

- Labeling updates
- Maintain regulatory status and commitments for approved products.
- Ensure regulatory impact assessments are performed for proposed changes.

Cross-Functional Coordination

- Work closely with Formulation R&D;, Analytical R&D;, QA, QC, Production, Engineering, Supply Chain, Pharmacovigilance and other functions.
- Coordinate project timelines and follow up on regulatory deliverables.




- Participate in project review meetings and provide regulatory inputs.
- Facilitate effective communication between regulatory and technical teams.

Compliance & Documentation

- Ensure regulatory activities comply with applicable laws, guidelines, internal procedures and quality systems.
- Maintain regulatory trackers, submission records, approval databases and regulatory correspondence.
- Ensure proper archival and retrieval of regulatory documents.
- Support internal audits, customer audits and regulatory inspections, as applicable.

Educational Qualification
- M.Pharm

Experience
- 9-15 years of relevant experience in Pharmaceutical Regulatory Affairs.
- Strong experience in formulation regulatory affairs and ROW market submissions.
- Experience in dossier preparation, regulatory submissions, deficiency responses and post-approval activities.
- Prior experience managing regulatory projects and/or a small regulatory team is preferred.

Technical Competencies

- Strong knowledge of pharmaceutical regulatory requirements.
- Good understanding of CTD/eCTD dossier structure and CMC requirements.
- Knowledge of formulation development and manufacturing processes.
- Understanding of stability requirements, specifications and analytical methods.
- Knowledge of variations, renewals and post-approval changes.
- Ability to interpret regulatory guidelines and translate requirements into actionable plans.
- Positive understanding of regulatory submission and lifecycle management processes.
- Proficiency in MS Office and regulatory document management systems.

📌 Opening For Regulatory Affairs Manager -Row (Formulation ) (Hyderabad)
🏢 MSN Group
📍 Hyderabad