Regulatory affairs

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.

Support Cross-functional team like Analytical Development, Formulation Development during product development and align documentation as per HC guidelines and Extend support for any other Regulatory related Function.

Demonstrated knowledge and understanding of CCDSs, US and EU labeling, and the dynamics of Labeling Team purpose and objectives 

Preparation, review and submission of Dossiers. Good exposure on Life Cycle Management. Handling Post approval & Pre approval