...regulatory authorities) on defined matters.
·
Face external audits / inspection, coordinate and communicate with external auditors / inspectors for compliance.
Qualifications
Expertise in regulatory compliance ...
...labeling materials with the Generics Law and other relevant laws.
c) Ensure regulatory support to GMP inspections if required
d)... ...relevant regulations (e.g. FDA
EMA).
Profici...
My client are seeking a highly skilled Regulatory Affairs Team Lead to join their dynamic team in India. The ideal candidate will have extensive experience in regulatory affairs, particularly in handling DCP submissions, and...
...submissions
About you:
Candidates with at least 7 years of regulatory generalist experience within a pharmaceutical company, CRO, CMO, or similar organisation, and strong experience in new MAA applications...
...Job Description
Job Title: Associate Regulatory Affairs Director I (International Regulatory Affairs)
Career Level - E
Introduction... ...improve regulatory consistency and to achie...
...Regulator Affairs with at least 3 years in the desired role in the pharmaceutical industry.
Good knowledge of product development / CMO cycles for European markets.
Good understanding of regulatory requirement...
...Job Description
1. JOB DETAILS:
Title:
Senior Manager, Medical Affairs
Reports to:
Sr. Director, Medical Affairs & Pharmacovigilance
Function
Medical Affairs & Pharmacovigilance
Department
...
...is responsible for managing global publication plan(s), publications budget for the respective products, collaborating closely with medical affairs colleagues, global development, discovery, regulatory, and affiliat...
Bangalore
Pooja Jain
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