Assistant Manager - Regulatory Affairs - Pharma

The Assistant Manager - Regulatory Affairs will play a key role in ensuring compliance with global pharmaceutical regulations and supporting product registrations across multiple geographies. The role involves preparing, reviewing, and submitting regulatory dossiers, maintaining compliance with evolving regulatory requirements, and collaborating with cross- functional teams to ensure timely approvals.

This position offers exposure to global regulatory frameworks, product lifecycle management, and strategic interactions with health authorities, making it a critical role in driving compliance and market access.

Areas of Responsibility:

- Prepare, review, and submit regulatory dossiers (CTD/eCTD) for product approvals and renewals.

- Ensure compliance with global regulatory guidelines (FDA, EMA, CDSCO, WHO, MHRA, etc.).

- Support clinical trial applications, variations, and post- approval changes.

- Maintain regulatory databases, track submissions, and monitor approval timelines.

- Collaborate with R&D, QA, QC, manufacturing, and commercial teams to ensure regulatory readiness.

- Provide guidance on labeling, packaging, and promotional material compliance.

- Monitor changes in regulatory requirements and proactively update internal teams.

- Assist in audits, inspections, and responses to regulatory queries.

Job Requirements:

- Education: B.Pharm / M.Pharm / M.Sc (Life Sciences)

- Experience: 7-12 years in Regulatory Affairs (preferably pharma industry).

- Certifications: Regulatory Affairs certification (preferred).

Skills:

- Strong knowledge of global regulatory guidelines and submission formats.

- Experience in CTD/eCTD preparation and electronic submission tools.

- Familiarity with clinical trial regulations, pharmacovigilance, and GxP compliance.

- Excellent communication and documentation skills.

- Ability to manage multiple projects under strict timelines.

- Detail- oriented, proactive, and collaborative mindset.