Job Summary
We are hiring a Senior Regulatory Affairs Manager for our operations in Gurgaon, India. This specialist position requires a highly experienced regulatory professional with deep knowledge of regulatory submissions, lifecycle management, and interactions with health authorities. The ideal candidate will have at least 7 years of relevant regulatory experience in pharmaceuticals, biologics, or medical devices, with a strong ability to manage complex projects and drive regulatory strategy for India & SAARC markets.
Key Responsibilities
Lead the development and submission of product registration dossiers, amendments, supplements, and periodic reports.
Act as a regulatory liaison throughout the product lifecycle to ensure timely approvals.
Engage with regulatory agencies to facilitate and expedite pending product registrations.
Participate in regulatory strategy, risk management, and CMC activities.
Provide guidance on manufacturing changes, line extensions, and technical labeling.
Serve as a regulatory consultant to internal teams such as Marketing, R&D, and Manufacturing.
Ensure continued compliance for both new and marketed products.
Required Skills & Qualifications
Associate Degree or higher in a relevant scientific field.
Minimum 7 years of experience in Regulatory Affairs, preferably within the pharmaceutical or medical device industry.
In-depth knowledge of regulatory submission processes, CMC requirements, and risk management.
Proven track record of successful interaction with regulatory agencies.
Strong understanding of India & SAARC regulatory landscape.
Excellent communication and project management skills.
Perks & Benefits
Competitive salary package (Not disclosed in JD).
Leadership role with regional regulatory responsibilities (India & SAARC).
Opportunity to drive regulatory strategies for diverse healthcare products.
Exposure to global regulatory standards and practices.
Company Description
A global leader in the healthcare and pharmaceutical industry, focused on developing innovative medical solutions and ensuring regulatory compliance across all markets. The organization offers a robust environment for career growth and learning in regulatory sciences.
Work Mode
On-site – Gurgaon, India
Call-to-Action
If you meet the above criteria and are ready to lead critical regulatory projects across India and SAARC, apply now to become part of our dynamic regulatory team!
Extracted Experience Requirement:
Minimum 7 years of experience in Regulatory Affairs..
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