Opening For Regulatory Affairs Manager -Row (Formulation )

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.
• Good understanding of regulatory submission and lifecycle management processes.
• Proficiency in MS Office and regulatory document management systems.