Title:  Senior Officer

Job Title:

Team Member - Regulatory Affairs

Business Unit:

R&D II, Regulatory Affairs And Global Pharmacovigilance

Job Grade

G12C/G12B

Location :

Pithampur

Responsibilities

1. Review, compile, and maintain regulatory documentation for sterile injectable products.
2. Support post-approval lifecycle management activities, including variations, renewals, amendments, supplements, notifications, and annual updates.
3. Coordinate the timely submission of regulatory applications and responses to health authority queries.
4. Review regulatory documents for completeness, accuracy, consistency, and compliance with applicable guidelines.
5. Maintain product registration details, approval status, commitments, submission trackers, and regulatory databases.
6. Assess the regulatory impact of proposed changes related to manufacturing processes, equipment, specifications, analytical methods, packaging materials, and manufacturing sites.
7. Coordinate with Quality Assurance, Quality Control, Manufacturing, R&D, Packaging Development, Supply Chain, and other functions to compile submission documents.
8. Review and approve artworks, labels, cartons, package inserts, and other packaging components for regulatory compliance.
9. Ensure approved product information and regulatory commitments are accurately incorporated into artworks and product documentation.
10. Track upcoming product registration renewals and ensure submission within prescribed timelines.
11. Support the preparation and review of responses to regulatory deficiencies, queries, and requests for additional information.
12. Coordinate with regional regulatory teams, partners, and external stakeholders for country-specific documentation requirements.

Travel Estimate

NA

Job Requirements

Education Qualification

M. Pharma

Experience

Tenure: 2-4 Years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).