Global Regulatory Affairs CMC Director

About the job

Job Summary

The Global Regulatory Affairs CMC Director is responsible for defining regulatory CMC strategy, leading and overseeing global CMC regulatory submissions to achieve timely approvals of clinical trials applications, marketing authorisation applications and post-approval lifecycle changes for biologic and biosimilar products.

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
• Define regulatory CMC content of regulatory applications and dossiers for product development, marketing authorisation and maintenance; coordinate preparation, writing and review of documents and dossiers
• 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