Manager - Regulatory Submissions

Description:

The Manager - Regulatory Submissions is responsible for planning, preparing, and managing regulatory submissions for pharmaceutical products to global health authorities. The role ensures that all submissions meet regulatory requirements and are delivered within defined timelines while maintaining high quality and compliance standards.

Responsibilities:

- Manage the preparation and submission of regulatory dossiers including IND, NDA, ANDA, and MAA submissions.

- Oversee electronic submissions using eCTD format to regulatory agencies.

- Ensure compliance with global regulatory guidelines including ICH and regional health authority requirements.

- Coordinate with cross-functional teams such as clinical, pharmacovigilance, quality, and manufacturing for submission documentation.

- Review regulatory documents for accuracy, completeness, and compliance.

- Track submission timelines, approvals, and regulatory commitments.

- Respond to regulatory authority queries and support inspection readiness.

- Maintain regulatory submission databases and document management systems.

- Lead and mentor regulatory affairs team members.

- Identify opportunities for process improvements in regulatory operations.

Required Skills:

- Strong knowledge of global regulatory submission processes.

- Experience with eCTD publishing and submission management.

- Knowledge of regulatory requirements from agencies such as U.S. Food and Drug Administration, European Medicines Agency, and Central Drugs Standard Control Organization.

- Understanding of ICH guidelines and global regulatory frameworks.

- Experience with regulatory information management systems (RIMS).

- Strong project management and documentation skills.

Qualification:

Experience: 8-12 Years

- Bsc/Msc

- Regulatory Affairs certification is preferred.