Walk-in interview for Regulatory Affiars @ HAB Pharmaceuticals, Mumbai.
Department: Regulatory Affiars
Position: Sr. Manager
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.
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.
Date & Time: 9th July – 11th July , 12.00 PM – 5.00 PM
HAB Pharmaceuticals and Research Ltd
310 TV Industrial Estate
SK Ahire Marg
Contact – Urvee ( 9769888314 )