About this role

Evaluation of regulatory documents, compilation of dossier and submissions to CDSCO-HQ for regulatory approval of drug substance and drug products.

Area of responsibility:

Evaluation of regulatory strategies for products to be registered in India
Review of CMC & other documents, coordination with cross functional teams for necessary corrections, preparation of cover letter of application & other regulatory documents, compilation of regulatory dossier and submission on the portal of regulatory authority for obtaining,
CT, BE and domestic manufacturing and marketing permission
Import & marketing approval in India
Compilation of IPC testing dossier and coordination for sample readiness and submission to laboratory
Post approval changes
Phase IV CT applications
Additional site notification/approval
Condition compliance
Checking artworks of product label and coordinate for necessary corrections

Preparation of prescribing information

Travel Estimate

Minimum 2-5 years of relevant experience
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).
Apply Now »
Apply Now
Apply Now
Start applying with LinkedIn
Start
Please wait...

Find similar jobs:

Executive – Regulatory Affairs