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.
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