Senior Regulatory Specialist

Dear Candidates,

We are hiring in our API Regulatory department for "Executive/Sr Executive/ Asst. Manager/Manager" at Shendra, Aurangabad location:

Job responsibilities:

1. Compilation and submission of Drug Master File (DMF) to USFDA, EDQM, Health Canada, Australia, China, Japan, Brazil and for EU countries

2. Submission of DMF amendments and variation filings to implement the post approval changes

3. Evaluation of change controls and perform regulatory assessment based on submitted DMF

4. Co-ordinated with cross functional team such as QA, QC, Production, ADL and R&D and review of documents received for registration purpose.

5. To Maintain regulatory database by following best regulatory practices

6. To prepare action plan for Defficiency letter response and timely Respond to defficiency letters

7. To provide Best in class API regulatory support to Customer

8. Knowledge of current regulatory guidelines and ICH guidelines

Candidate with minimum 5-12 years of experience in regulatory affairs API, for submission of USDMF, EDQM CEP, CADIFA - Brazil, Health Canada, EU-ASMF.

Life cycle management of DMF to keep the DMF upto Date.

To respond to Health Authorities defficiency letter for successful approval of MAA.

Educational Qualification: M.Sc. or equivalent

Interested candidates can share their CVs at amrutar@harmanfinochem.com or vijaykatre@harmanfinochem.com