Job Summary
We are looking for an experienced Regulatory Affairs Manager – ADC for our Regulatory Affairs team in Mumbai, India. This specialist role requires a regulatory professional with comprehensive knowledge in product registration, lifecycle management, and interaction with health authorities. The candidate will lead and execute complex regulatory projects, including strategy development, risk management, and CMC activities, ensuring the timely approval of new drugs, biologics, or medical devices.
Key Responsibilities
Direct development and submission of product registration dossiers, progress reports, amendments, and supplements.
Serve as the regulatory liaison throughout the entire product lifecycle.
Collaborate with regulatory agencies to expedite product approvals.
Participate in product planning, regulatory strategy, risk assessment, and CMC activities.
Ensure timely approvals of new and marketed products in compliance with regulations.
Provide guidance to development and marketing teams on regulatory interpretations, manufacturing changes, and technical labeling.
Represent regulatory affairs in cross-functional teams including marketing, R&D, and manufacturing.
Required Skills & Qualifications
Associate Degree or equivalent in a scientific discipline.
Minimum 7 years of experience in Regulatory Affairs, preferably in pharmaceuticals, biologics, or medical devices.
Strong expertise in regulatory submission processes and lifecycle management.
Excellent knowledge of regulatory guidelines, CMC, and risk management.
Proven ability to liaise with regulatory agencies.
Strong communication, problem-solving, and project management skills.
Perks & Benefits
Competitive compensation package (Not specified in JD).
Leadership role in a globally reputed pharmaceutical company.
Exposure to global regulatory practices and multi-functional collaboration.
Professional development opportunities in regulatory strategy and management.
Company Description
A global healthcare leader dedicated to innovation, quality, and regulatory excellence. The company focuses on developing and delivering pharmaceutical and medical device products that meet the highest standards of safety and efficacy across diverse markets.
Work Mode
On-site – Mumbai, India
Call-to-Action
If you are a regulatory expert ready to drive product approvals and strategic regulatory initiatives, apply now to join our dynamic Regulatory Affairs team in Mumbai!
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