DRA

Bachelors, Master degree or PhD in science, math, engineering or related discipline; The Principal, Regulatory Affairs, Intelligence, Materials is expected to perform with minimal supervision and is an experienced and detail-oriented professional with expertise in materials and with an understanding of the interplay of materials and medical devices, pharmaceuticals and combination products.

Dossier and document preparation as per CTD,ACTD and country specific guidelines, Review of dossiers, DMF and Technical documents, Answer query raised from regulatory authority, package insert, SmPC, PIL & MSDS preparation

They have to make dossier, Review the documents. Should have the knowledge of making CTD, ACTD and courtly Specific dossier.

Sr. Specialist Regulatory Affairs will independently, with minimum supervision, initiate and prepare the regulatory submissions, interact with Business Units Regulatory affairs teams and interact with regulatory agencies/health authorities to obtain and maintain product approvals with a focus on India, Sri Lanka and other SWA Countries, as per the country specific regulations.

A Graduate, Post graduate in Pharmacy. Collation, compilation and timely dispatch of required regulatory documentation to Apotex affiliates/customer and follow-up on timely submission of applications to the health authority.

Ph.D. in relevant discipline with first class or equivalent at the preceding degree i.e. Master Degree in Pharmacy, Forensic Pharmacy with specialization in Pharmacology or relevant discipline with very good academic record throughout.

M.Pharma, MSC with 3 to 8 years of relevant experience HPLC, GC method development for OSD having exposure to regulated, Semi Regulated & India markets including

Pharmaceutical Regulatory Affairs and Management ; Ph.D in relevant discipline and MPharm Pharmaceutical Regulatory Affairs/ Quality Assurance