Associate Director Regulatory Affairs CMC
3 weeks ago
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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