CMC Manager
Location: Mumbai, India
Category: Regulatory Affairs
Role Summary
The CMC Manager leads and supervises a team of 2+ professionals within the Regulatory Affairs Sub-Function, providing guidance, mentorship, and coordination. This is a first-level management role without direct budget or hiring/firing authority.
The role ensures the timely regulatory approval of new drugs, biologics, or medical devices and maintains continued approval of marketed products.
Key Responsibilities
Team Leadership & Supervision:
Lead and supervise professionals in the preparation of product registration submissions, progress reports, supplements, amendments, and periodic experience reports.
Mentor, coach, and coordinate team activities.
Regulatory Interaction:
Serve as a regulatory liaison throughout the product lifecycle.
Interact with regulatory agencies to expedite pending approvals.
Regulatory Strategy & Compliance:
Participate in product plan development, regulatory strategy, risk management, and chemistry, manufacturing, and control (CMC) activities.
Advise development and marketing teams on manufacturing changes, line extensions, technical labeling, and applicable regulations.
Cross-Functional Representation:
Act as regulatory representative to marketing, research teams, and regulatory agencies.
Ensure timely approval and continued compliance of products.
Qualifications
Education:
Bachelor’s degree or Associate’s degree (~13 years of education) in a relevant field.
Experience:
Minimum 4 years in regulatory affairs or related roles.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
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Auckland |New Zealand :
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Madrid |Cebu Province :
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Manila |Croatia :
Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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