Regulatory Affairs Specialist (RAD-US Market,CMC, M3) Creeno Solutions

6.0 - 11.0 years

10 - 18 Lacs

hyderabad

Work from Office

Position: RAD-US Market, (CMC, M3) Qualification: M. Pharmacy (Pharmaceutics, Regulatory Affairs) Experience: 6-11 yrs Job Location: Hyderabad Job Type: Permanent Responsibilities: Hands on experience with RA-US market ; responsible for Approved and Tentative Approved ANDAs /NDAs [i.e., filing of supplements (CBE, CBE-30, PAS, Response to Queries, Controlled Correspondence, Annual Reports** /Updates etc.,) Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers. Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality, an...

Posted 4 weeks ago

AI Match Score

Apply

Tender Manager/ Manager Sr. Manager Hetero

12.0 - 15.0 years

15 - 17 Lacs

mumbai

Work from Office

Tender Management (Manager/ Sr. Manager) at Hetero Labs Ltd (International Marketing) managing following Regions: - 1) Overall Africa (More Focus is on East and SADC) 2) North Africa 3) Iran Experience Level: 12-15 years Candidate should be ready for frequent travel to African countries Position is based out of Mumbai Office (Ville Parle East) Pharma background mandatory Roles & Responsibilities are given below: Pre-Working/on working/Post Working of Tenders prohibited locally with any funds To collect Tender information from various sources -Government, NGO, Missionary, Develop a country level tender calendar. To Build strong relationship with Ministry of Industry & commerce to facilitate a...

Posted Date not available

AI Match Score

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.