HAB Pharmaceuticals & Research Ltd – Walk-In for Senior Manager – Regulatory Affairs on 9th – 11th July 2020
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.
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)
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube