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Senior Manager Job In Regulatory Affairs at Abbott India Limited

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Senior Manager Job In Regulatory Affairs at Abbott India Limited

Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, iversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.

Post : Senior Manager Regulatory Affairs - DCGI Filing

Job Description
• Responsible for end-to-end filing of all DCGI/FSSAI  products from Inhouse development
• Responsible for complete RA due diligence of all new products from TPK/IL /Co-development/Acquisition
• Track all SEC meetings and recommend possibilities for new products across all 3 affiliates
• Recommend new products/ideation  on new notifications in Drugs/FSSAI recommend products or ideas for new products
• Propose efficient Regulatory pathway for all “GO” Organic/Co-dev products  by liasoining with clinical ,medical and RA internal function
• Responsible for implementation of milestones , timelines and Investments for all “Go” projects from I&D
• Responsible for end to end all DCGI meetings including Subject expert committee (SEC) meetings for product approvals within the organization including planning, co-ordinating, working on slides with CFT teams for SEC presentation
• Responsible for response of all queries raised  by regulatory authorities on new products both internal and external
• Project management for all new products from in-house development
• Work with government affairs team to build case for NPPA price fixing for new formulations.
• Potential advocacy in FSSAI /Ayush /OTC

Candidate Profile
Education : M.Pharm / Degree in Regulatory Affairs
Experience 8-10 years in DCGI filings /new launches


Organic
• Plan RA strategy
• CMC filing
• SEC
• Test license
• MA approval
• SLA approval
• Project Management

Inorganic
• DD
• Review documents – CMC, Clinical , licenses
• Playbook
• RA pathway
• Clinical pathway
• Filing strategy
• Timelines

Additional Information
Experience : 8-10 years
Qualification : M.Pharm / Degree in Regulatory Affairs
Location : Hyderabad
Industry Type : Pharma


End Date : 30th December, 2021

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