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Senior Manager - Regulatory Affairs

10+ years
Not Disclosed
10 July 28, 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

 

Senior Manager – Regulatory Affairs

Location: Mumbai, India
Work Mode: On-site
Experience Required: Minimum 10 years
Salary Range: Not specified (industry standard based on experience)


Job Summary

Abbott is hiring a highly skilled Senior Manager – Regulatory Affairs to lead strategic and operational regulatory activities for India and global markets. The role involves regulatory submissions, lifecycle management, risk mitigation, compliance, and agency interactions. This is a critical opportunity for seasoned professionals aiming to impact regulatory strategy and product registration in a global pharmaceutical organization.


Key Responsibilities

  • Lead complex product registrations and submissions for new product launches.

  • Develop regulatory strategies across the product lifecycle.

  • Prepare and respond to regulatory deficiency letters.

  • Act as the regulatory lead in cross-functional meetings and global communications.

  • Manage change requests, risk mitigation, and compliance actions.

  • Conduct health authority interactions and coordinate with global affiliates.

  • Identify and implement regulatory process improvements.

  • Provide expert support in licensing reviews and due diligence.

  • Maintain up-to-date expertise on global regulatory guidelines and product requirements.


Required Skills & Qualifications

  • Bachelor's Degree in Pharmacy, Biology, Chemistry, Pharmacology, or related field.

  • Minimum 10 years of experience in Regulatory Affairs, R&D, or Manufacturing.

  • Strong knowledge of global regulatory requirements and local legislation.

  • Expertise in dossier preparation, lifecycle management, and change control.

  • Proven leadership and decision-making skills in high-impact regulatory functions.

  • Excellent communication and stakeholder management skills.

  • Ability to mentor and guide junior staff when required.


Perks & Benefits

  • Competitive industry-aligned compensation

  • Exposure to global regulatory frameworks and multinational collaboration

  • Access to leadership and professional development programs

  • Work with cutting-edge pharmaceutical technologies

  • Stable and inclusive workplace culture focused on integrity and innovation


About the Company

Abbott is a global healthcare and pharmaceutical leader, known for delivering innovative diagnostics, medical devices, nutrition, and branded generic medicines. With a legacy of over 130 years and a strong presence in India, Abbott continues to transform lives through science-based healthcare solutions.


Job Type

Full-time | On-site | Senior-Level


Call to Action

Are you ready to lead global regulatory strategy and drive product approvals at one of the world’s top healthcare companies? Apply now and bring your regulatory expertise to Abbott in Mumbai.