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Senior Manager - Regulatory Affairs

Abbott
Abbott
10+ years
Not Disclosed
10 July 4, 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 Manager – Regulatory Affairs

Location: Mumbai, India
Experience Required: 10+ years
Education Required: Bachelor’s in Pharmacy, Biology, Chemistry, or Pharmacology
Work Mode: On-site


Job Summary

A top pharmaceutical company in India is hiring a Senior Manager – Regulatory Affairs to lead complex regulatory submissions, ensure compliance throughout product lifecycle, and represent the organization in key regulatory discussions. The ideal candidate brings 10+ years of pharma regulatory experience, strategic leadership, and the ability to manage regulatory risks, health agency interactions, and regional collaborations.


Key Responsibilities

  • Lead complex product registrations, submissions, and responses to deficiency letters.

  • Drive global and domestic regulatory strategies across product lifecycle stages.

  • Act as subject matter expert on legislation, regulatory changes, and industry developments.

  • Review and approve change requests, ensuring timely file updates and compliance.

  • Represent Regulatory Affairs in cross-functional meetings and provide expert consultation.

  • Maintain coordination with regional product leads and affiliate teams.

  • Prepare and lead health agency interactions and audits as regulatory lead.

  • Oversee regulatory due diligence, risk mitigation, and strategic improvements.

  • Continuously update knowledge of global regulatory requirements and assigned product areas.


Required Skills & Qualifications

  • Bachelor’s degree in Pharmacy, Chemistry, Biology, Pharmacology, or related field.

  • Minimum 10 years in regulatory affairs, R&D, or manufacturing within pharma.

  • Expert knowledge of global regulatory guidelines and product lifecycle management.

  • Proven experience with Indian and international health authority submissions.

  • Strong leadership, communication, and cross-functional collaboration skills.

  • Ability to proactively identify risks, innovate solutions, and mentor junior team members.

  • Familiarity with global regulatory strategy, licensing, and regulatory software tools.


Perks & Benefits

  • Competitive salary based on experience

  • Global exposure to regulatory strategy and health authority processes

  • Opportunity to work with cross-functional teams and lead innovation

  • Continued professional development and internal leadership support

  • Health insurance, paid leave, and performance incentives


Company Description

This leading global pharmaceutical organization focuses on quality-driven healthcare innovation, regulatory excellence, and global compliance. With a deep commitment to regulatory strategy and lifecycle management, they deliver impactful therapies while ensuring international standards are met.


Work Mode

On-site (Mumbai, India)


Call to Action

Ready to shape the future of regulatory excellence? Apply now and lead end-to-end product compliance and global submissions at a top-tier pharmaceutical company in Mumbai.