DRA

Regulatory Affairs Manager in the Regulatory Business Development Post Deal Management group is a regulatory specialist with project management capabilities responsible for both regulatory life cycle maintenance submissions and managing successful application transitions for products that are either divested or acquired.

Dossier submission and review of Module 1, 2 and 3. ANDA submission. DCP, MRP, National Filing for various EU countries. 

Accountable for regulatory transition activities to achieve relevant project turning points, as well as core business development operational activities including but not limited to running the green light process, preparation of documentation and risk, issue management.

A Post-graduate, Graduate degree in Chemistry, Pharmacy, Life Sciences. Candidate should have knowledge about Post-approval change submission requirement and compilation of variation packages for US, CAN, EU, AUS-NZ, ROW markets.

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.