Sr Manager - Regulatory Affairs - GRA CMC (Thane)

Organization: Reputed MNC

Work Location India - Mumbai

Functional Area Regulatory Affairs

Job Description Leads the GRA CMC group based in India, acts as the senior point of contact for all RA CMC related activities in Thane / Indian labs

• Senior member of GRA CMC organization in India accountable to manage the CMC deliverables according to strategy / decision / plan set by Management /Head GRA CMC
• Interacts closely with the Global RA CMC organization for all projects or products developed or supported at Thane labs and reports progress and issues proactively.
• Operates closely with local site management in Thane for OTC R&D.
• Manages all regulatory CMC activities for allocated projects or products: e.g., but not limited to, Venous subcategory (new files, renewals, variations).
• Member of Category Global Regulatory Team for assigned projects/products.
• Collaborates strongly with Category Liaisons to handle shared activities and accountabilities with Sandoz India for GI US products containing PPI.
• Ensures high quality interactions with HAs for CMC aspects and supports local /regional regulatory organizations for advisory meetings with agencies or any other technical contacts to defend submission strategy or challenge file evaluation outcomes for allocated projects /products.
• Accountable to deliver high quality registration / accreditation documents according to plans for assigned local and global projects and products.
• Establishes RA CMC strategy and executes global/regional technical regulatory activities in collaboration with the Regional RA Liaisons (North America, Europe, SGM) as appropriate to support Category objectives.
• Provides RA CMC advice and training for the Thane Pharmaceutical and Analytical Development teams and to the Thane technical documentation cell associates with respect to regulatory CMC topics and deliverables.
• Supports Due Diligence activities as required for assigned projects and delivers inputs for ER, DR and Scope changes in Ideal process, in terms of technical information, RA CMC requirements and evaluation of resources needs.
• Acts as Member of the GEMA CMC platform team, supports full implementation and use of GEMA CMC cabinet and interacts with Global Reg Ops for e-submission activities.
• Implements RA CMC initiatives, contribute to special assigned activities and projects and rep-resents GRA in cross functional teams (e.g. RSEC, QA.. ).

The experience in a multinational company with relevant personal involvement in EU and USA CMC regulatory affairs activities (registration files, variations, knowledge of international guidelines, document management system) is a must.
Minimum requirements Minimum Qualification

Minimum MPharm, Preferred PhD

Minimum requirement of atleast 10-12 years of relevant experience

Post your resume to gangotrinath@gmail.com (or) ravi.namana@gmail.com