Associate Manager - Regulatory Affairs - API Regulatory - DMF Filing/Submission

We are looking for a Regulatory Affairs Associate Manager for a Global Pharmaceutical company at Bangalore.

Role & Responsibilities:

1) DMF submission to global markets & handling health authority queries.

2) Handling Post approval changes.

3) Providing Regulatory input for new molecule development.

4) Customer queries and support.

Job Profile:

- Experience in Compilation of DMFs (Dossiers for CEP, CTD's, USDMF's) accordance to the filling requirements of Regulatory authorities and periodic updating USDMF's

- Experience in Compilation and submission of Amendments, Annual updates to USFDA.

- Experience in Compilation of different kinds of Amendments (Scale-up, SM vendor change along with any process changes) to both EDQM and USFDA for the submitted DMFs.

- Experience in the Compilation and submission of ASMFs

Experience in issuing LoA's to customers referring to DMFs.

Issuing LoA's to Europe (National, De-centralized and Mutual Recognition Procedure), US and Canada markets.

Experience in addressing the responses to deficiencies received from various regulatory authorities (EDQM/EU/US).

Experience in addressing the responses to queries received from various customers on Applicant part of DMF.

RA - API Regulatory - DMF filing / Submission

Qualification : M.Sc. / M. Pharm./ B. Pharm.

Experience : 10 Years To 14 Years

Job Location : Bangalore.