Associate Director Regulatory Affairs CMC

Found in: Appcast UK C2 - 1 week ago

United Kingdom wax. Full time

Our client, a successful and growing Biotechnology organisation, is looking to hire a new addition to the Regulatory CMC team.


This role is responsible for preparing regulatory CMC submission strategy for rare disease drugs (both biologics and small molecules) and an opportunity to design creative solutions in order to obtain approval for initial BLA/NDA as well as post-approvals variation in ROW markets.


Key responsibilities: -


Prepares various regulatory CMC documents in a timely and appropriate manner according to the product development plan

Manages regulatory schedules for product development plan and submissions

Working with internal concerned departments, prepares appendices attached to regulatory CMC documents to be submitted to regulatory authority and submits them

Develops and manages innovative regulatory CMC strategies and risk assessments for biologics and small molecules

Contribute to the Global Regulatory CMC Strategy

Responsible for direct contact/liaison with various health authorities on specific CMC topics.

Manages and directly contributes to HA meeting briefing documents in collaboration with global regulatory

Assures that appropriate contacts with Health Authorities

Explores opportunity for efficiency improvement in the dossier preparation process and takes actions to promote new ideas

Conducts regulatory impact assessment and provide appropriate regulatory strategy for these changes that requires regulatory actions

Manages and directly contributes to the CMC writing, preparation, review and approval of regulatory CMC dossiers for submission in collaboration with global CMC Dossier



Suitable applicants will have: -


Knowledge of global regulations/guidelines, Key Health Authority/Industry thinking and trends, and be capable of resolving strategic technical and regulatory issues. quality consultations and other CMC focused regulatory meetings in collaboration with Global regulatory and other CMC functions

Experience in preparation and submission of post-marketed CMC change controls for biologics and small molecules


********This company offers a great culture and a competitive package********

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