Global Regulatory Affairs Cmc Director

5 days ago

Singapore PRESTIGE BIOPHARMA LIMITED Full time

**_Job Summary
- **

The incumbent will:

- Provide expert advice to Senior Management and act as the global point of contact in the areas of CMC regulatory affairs.
- Act as global regulatory CMC lead for assigned development projects and define and execute Regulatory CMC Strategy from pre-clinical stage up to and including marketing authorisation
- Plan, prepare and conduct all CMC related aspects for interactions with national authorities and supra-national agencies (e.g., MPA, PEI, EMA, FDA, as well as WHO when relevant) in the scope of product development including market authorisation
- Set up, adjust and continuously optimize regulatory CMC processes and interfaces (internal and external)
- Monitor changes and evolution in the regulatory CMC landscape for therapeutics (Regulatory Intelligence); analyse the impact of drug changing regulations for Prestige´s products; and collect, evaluate, and disseminate relevant regulatory updates on competitors' developments

**_Main Tasks _**
- Develop global product regulatory strategies to optimize time to approval by Health Authorities (e.g FDA, EMA etc)
- Review CMC submissions and responses to Health Authorities in line with agreed global regulatory strategy and timelines
- Represent Prestige RA CMC in Health Authority meetings and lead preparation activities for meetings with Health Authorities on CMC related matters
- Interact directly with international Health Authorities, as required participate in and/or facilitate agency meetings.
- Develop and maintain constructive relations with key internal and external colleagues, e.g. cross functional colleagues within Prestige, with Alliance Partners, vendors and Health Authority representatives.
- Lead cross-functional teams responsible for the preparation of submissions and responses to Health Authority CMC questions at any phase of product development
- Ensure effective communication of CMC regulatory strategy, risks, and overall plans to leadership and cross-functional teams
- Accountable for the coordination and overall global approval of regulatory assessments for CMC changes
- Conduct coaching & training of staff pertaining to CMC and regulatory conformance
- Lead team members that define CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement
- Represent the Company with local and global regulatory authorities, vendors and corporate partners

**_Requirements _**
- PhD in biological science, chemistry or related discipline
- Minimum of 10 years relevant experience in Global Regulatory Affairs CMC during clinical, registration and/or post-marketing for Biologics and Vaccines
- Knowledge of CMC drug development (Drug Substance and Drug Product) and knowledge of multidisciplinary functions involved in drug development and manufacturing
- Demonstrated inclusive leadership, strategic thinking and change management to achieve business goals
- Proven ability to manage projects and multi-disciplinary teams across global locations and time zones
- Good combination of strategic and operational skills; ability to make flexible, but thorough decisions in a highly dynamic environment
- Excellent communication skills in English

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