Sr. Executive- Regulatory Affairs ( Europe Market)

Designation :- Regulatory Affairs :- Sr. Executive / Asst. manager ( For Europe Market)

Education: - B. Pharm/ M. Pharma/Any Graduate

Experience:- min. 3 years

Salary: As per Industry

Job Location: Vashi, Navi Mumbai

Job Description: -

• Europe market, handling Dossier preparation and compilation (CTD, ACTD and country specific), dosage form like Tablet, Capsule, injection etc. in FORMULATION.
• Should be well versed with the guidelines of ICH and other regulatory.
• Should be well versed with the preparation of documents for license application.
• Should be well versed with the preparation of documents for COPP, FSC and other legal documents.
• Should be well versed with the preparation of registration documents as per ACTD, CTD, country format.
• Preparation of text matter and checking of artworks.
• Should coordinate with factory for samples, working standards, document data, license related documents.
• Should have knowledge with regard to checking of samples.
• Courier of documents and samples to respective customer.
• Maintaining status and record of dossiers, samples & legal documents.
• Reply of queries.
• Co-ordinate with regard to legalization of documents.
• Maintaining record of registration status and re-registration.

* Candidates who are able to attend the interview F2F need to apply only.

Thanks & Regards

PSA Chemicals & Pharmaceuticals Pvt. Ltd.

Email ID:- hrd1@psachem.com / hrd@psachem.com

Mob. No.:- 8591920363