The role is responsible for supporting endtoend regulatory lifecycle management activities for assigned products in the local market. This includes preparation and maintenance of countryspecific regulatory documentation, coordination of postapproval changes, and ensuring compliance with national regulatory requirements. The position also supports audits/inspections and collaborates with crossfunctional teams (Quality, Supply Chain, Pharmacovigilance, Medical, Commercial) to maintain regulatory compliance.
Key Responsibilities
- Preparation, Organization & Coordination of Local Regulatory Documentation
- Prepare, compile, and review countryspecific regulatory documentation (e.g., Module 1, administrative forms, declarations, national templates) in accordance with local health authority requirements.
- Support regulatory submissions including new registrations, renewals, variations, PSURs/PBRERs, safety updates, label updates, and CMCrelated changes.
- Maintain and update local regulatory databases (VEEVA RIMS), tracking systems, and product registration archives to ensure compliance with local legislation.
- Ensure that all documents meet formatting, quality, and content standards required for national submissions.
- Liaise with global/regional RA teams to obtain submission components and ensure alignment with global dossiers.
- Provide Local Input for PostApproval Changes & Change Control
- Evaluate change control notifications related to manufacturing, quality, safety, or labelling changes and provide countryspecific regulatory impact assessments.
- Work with global/regional RA, Quality, and Supply Chain teams to ensure timely implementation of postapproval changes as per national regulatory timelines.
- Prepare and submit variation dossiers or notifications based on local regulatory classifications and guidelines.
- Track approval timelines and ensure that all regulatory commitments arising from changes are fulfilled promptly.
- Support in Audits, Inspections & Regulatory Compliance
- Support the local RA representative during internal audits, external audits, and health authority inspections.
- Coordinate and prepare documentation required for inspections, ensuring readiness of RA records and systems.
- Assist in responding to audit observations and regulatory findings.
- Collaborate with crossfunctional teams to ensure timely closure of Corrective and Preventive Actions (CAPAs).
- Ensure continuous compliance with evolving national regulations and proactively identify potential risks.
Key Skills & Competencies Required
- Strong knowledge of global regulatory guidelines and understanding of the CTD/eCTD structure, especially Module 1.
- Experience in lifecycle management: renewals, variations, PSUR/PBRER submissions, label updates, CMC changes.
- Familiarity with change control processes and regulatory impact assessments.
- Good documentation skills and attention to detail.
- Ability to work effectively with crossfunctional and global teams.
- Strong organizational, planning, and communication skills.
- Prior experience with regulatory databases or submissiontracking tools is an advantage.
Ideal Candidate Profile
- 4+ years of experience in Regulatory Affairs (Pharma or Biologics).
- Understanding of Indian regulatory requirements for pharmaceuticals.
- Experience in module preparation and lifecycle submissions.
- Ability to handle multiple projects and meet submission deadlines.
- Comfortable working in a fastpaced, compliancedriven environment.
