Executive- Drug Regulatory affairs (Mumbai)

Executive- Drug Regulatory affairs (Mumbai)

06 Aug
|
Wockhardt
|
Mumbai

06 Aug

Wockhardt

Mumbai

Wockhardt is a true Indian Multi-National Company with a multi-ethnic workforce of 5000 Associates from 27 different nationalities globally. We have 3 research centers and 12 manufacturing plants, with businesses ranging from the manufacturing and marketing of Pharmaceutical and Bio-pharmaceutical formulations, Active Pharmaceutical Ingredients (APIs) and Vaccines.

The company has successfully created an integrated multi-technology capability to manufacture all types of dosage forms including sterile injectable and lyophilized products. Highly skilled technicians operate 12 manufacturing facilities that are US FDA, UK MHRA and EMEA compliant sites in India, the US and Europe. It is with immense joy and pride we share with you that Wockhardt Group has won 3 awards in the Great Place To Work contest.

We have been recognized by renowned institutions worldwide for our aim to provide quality healthcare, including the Europe Business Assembly, Oxford, Great Britain for being the `Best Enterprise. In the past two years, Wockhardt has won 109+ Awards at National & International level, and the number is still increasing!

We have a requirement of Executive for Drug Regulatory Affairs in our HO in BKC

Job description

PROPOSED PROFILE:

1. Candidate should be a pharma graduate / post graduate

2.



Candidate should have completed degree/diploma course of regulatory affairs.

3. Candidate should have minimum 18 months experience in working in regulatory affairs department.

4. Candidate should have thorough knowledge of CTD/eCTD/ACTD dossiers

5. Candidate should be well versed with portal upload of dossiers.

6. Candidate should have positive communication skill in English, Marathi and Hindi.

7. Candidate should be ready to travel to CMS locations when there is a need.

RESPONSIBILITIES:

1. Candidate has to compile dossiers as per re-registration / registration requirements.

2. Candidate have to keep timely records and archival of registration status.

3. Candidate has to arrange for registration samples.

4. Candidate has to keep records of all legal documents such as License, COPP, GMP, FSC, Trade mark registration

5. Candidate has to help business team in technical submission of tender.

6. Candidate has to arrange couriers of attested documents, registration samples to various country manager / distributors and track the shipment details.

If you are interested in exploring this opportunity kindly share your updated resume on this mail id [email protected]

📌 Executive- Drug Regulatory affairs (Mumbai)
🏢 Wockhardt
📍 Mumbai

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