Walk-In for Senior
Manager Regulatory Affairs, Pharma, Mumbai
Company: HAB PHARMACEUTICALS AND RESEARCH LTD
Roles and Responsibilities
1) Should be able
to lead and guide regulatory team and demonstrate high level knowledge of
country regulations and regulatory guidelines as updated from time to time.
2) Escalate issues
which can delay submissions of registration dossiers & tender documents.
Also should provide technical consultation and advice on regulatory strategy.
3) Thorough
check/review of documents/dossiers to maintain quality submission and support
of registration dossiers. Identification & Rectification of errors in
compiled dossiers before submission to Ministry of health.
4) To achieve
his/her responsibilities within the agreed timescales
5) Should have
faced the regulatory audits and have to visit the manufacturing siteif required
6) Supporting and
enabling effective and efficient communication that results in operational
excellence.
7) Collaborate with
internal and external clients,
Desired Candidate Profile
Thorough knowledge
of FDA regulation of India, Drugs and Cosmetics Acts and rules of India and
also regulatory guidelines.
Should understand
various types of dossiers such as CTD and A CTD and all others.
Must be from Science / Pharmacy background with Min 6 months of Experience in same line.
Excellent command over written and verbal English communication.
Should be self motivated and result oriented.
Should be initiator, keen learner, proactive and good analytical skills.
Should have pleasing and presentable personality.
Must be from Science / Pharmacy background with Min 6 months of Experience in same line.
Excellent command over written and verbal English communication.
Should be self motivated and result oriented.
Should be initiator, keen learner, proactive and good analytical skills.
Should have pleasing and presentable personality.
Date & Time: 9th
July - 11th July , 12.00 PM - 5.00 PM
Venue:
HAB Pharmaceuticals
and Research Ltd
310 TV Industrial
Estate
SK Ahire Marg
Worli--
400030
Contact
- Urvee ( 9769888314
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