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Senior Executive - Regulatory Affairs (Biologics)

0-2 years
Not Disclosed
10 April 30, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title:

Senior Executive – Regulatory Affairs (Biologics)
(Designation: Executive / Senior Executive)


Company:

Sun Pharmaceutical Industries Ltd


Location:

Gurugram / Mumbai / Vadodara – R&D


Posting Date:

April 7, 2025


Job Summary:

The Senior Executive in Regulatory Affairs for Biologics will be responsible for supporting market extension filings, lifecycle management, and regulatory submissions for biologic products across global markets. The role requires a solid understanding of regulatory frameworks, documentation standards, and technical aspects of biologics, along with the ability to independently manage global regulatory activities.


Key Responsibilities:

  • Handle market extension filing and post-approval lifecycle management for biologic products.

  • Understand and interpret technical details of biological products for regulatory submissions.

  • Support preparation, compilation, and submission of country-specific dossiers (MAA, LCM, post-approval changes).

  • Maintain and contribute to global regulatory submissions.

  • Review and perform gap analyses for registration in emerging markets.

  • Track and manage effective change control processes.

  • Review and assess Marketing Authorization Applications (MAAs) and variations for submission in global markets.

  • Assist in the preparation and review of Standard Operating Procedures (SOPs) and Work Instructions.

  • Stay current on local and international regulatory guidelines and trends.


Required Skills and Qualifications:

  • Bachelor's or Master’s degree in Pharmacy, Biotechnology, or a related field.

  • Experience with regulatory submissions for biologics (NDAs, BLAs).

  • Familiarity with global and emerging market regulatory environments.

  • Strong documentation and analytical skills.

  • Effective independent working capabilities and collaborative approach.

  • Excellent communication skills.