Maintain robust governance for label changes triggered by safety signals, clinical/CMC updates, and regulatory intelligence; ensure harmonized global implementation timelines and traceability.
Regulatory Affairs experience in the US and Canadian markets, with expertise in OSD and Injectable submissions, strong knowledge of AN DA and eCTD, proven team handling and leadership skills, and regulatory exposure to both.
D.Pharm with MPC ; M.B.B.S or Graduate in Health Sciences (B.D.S/B.A.M.S/B.H.M.S/B.U.M .S/B.P.Th /Nursing Basic/(P.B.Bsc)/B.Pharm/+ MPH/MHA/MBA in Healthcare Adminstration
PhD in Engineering OR MTech/ ME or equivalent degree with minimum 3 years relevant experience OR BTech/BE or equivalent engineering degree with minimum 5 years of experience.
Ph.D/MD/MS/MDS or equivalent degree or having 3 years of research, teaching and design and development experience after MVSc/M.Pharm/ME/M.Tech with at least one research paper in Science Citation Indexed (SCI) journal
M.Sc. / M.Tech (Medical or Human Genetics / Biochemistry/ Molecular Biology/ Biotechnology / Life Sciences / Applied Biology). Candidates should have minimum six months experience in HLA/ Molecular Biology Lab.
First class Post Graduate Degree, including the integrated PG degrees Or Second class Post Graduate degree, including the integrated PG degrees with PhD