Regulatory affairs

Review of the development documents and CMC documents as per regulatory standards. Gathering, managing and collating information from respective stake holders.

Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, Certificates of Pharmaceutical Product, Legal documentation e.g. Letters of Authorisation, Powers of Attorney, Translations of regulatory documentation

Application are invited for the post of Professor, Associate Professor, Assistant Professor from eligible candidates on Non grant basis.

Good Exposer On Life Cycle Management, Handling Post Approval & Pre approval, Knowledge on MAA (Marketing Authorization Application), Experience in CMC, Variations.

The Manager in the Global Regulatory Intelligence team is a hands-on contributor responsible for gathering and organizing regulatory intelligence under the guidance of the RI Director.

Lead Regulatory strategy and implementation for assigned TA and oversight of execution of strategy, timely submission, query responses, SEC meetings.

Review of all the documents received from stake holder for dossier compilation , Query response and Life cycle management

Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products

Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies.