Regulatory Manager CMC
* As a Regulatory Manager you are responsible for the development and execution of European Regulatory CMC strategies, submissions and compliance activities for biopharmaceutical projects/products from development to market and post-marketing, including the preparation and submission of correspondence and applications (IMPD's, MAA's,…) to regulatory agencies. Potential project responsibilities may include monoclonal antibodies, other recombinant proteins, vaccines, peptides and nucleotides. Depending on experience, you may act as CMC liaison with regulatory authorities to discuss and define submission contents and strategies.
* You lead the preparation of CMC information for submission to EU regulatory agencies, you generate CMC strategies, assesses risks and develop contingency plans. You ensure that CMC regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements. You support preparation of interfaces with Boards of Health, including scientific reviewers, administrative staff,… in order to discuss and define regulatory applications (Quality Module, Responses, Commitments. Depending on experience, you may act as CMC representative in formal meetings and teleconferences with regulatory authorities.
* As EU CMC representative you act as and contribute support to the Global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions.
* You are accountable for assigned CMC programs, managing day-to-day delivery of plans and strategic activities for specific projects, including Life Cycle Teams and compliance of commercial products.
* You may operate independently to resolve complex issues and manage regulatory risks and ambiguous situations within project teams. You investigate opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems.
* You create / contribute to the development of internal policies, processes and procedures supporting the progression and maintenance of the Pfizer biopharmaceutical portfolio at large. You lead document management and information management teams, within Global CMC / groups outside Global CMC.
* As EU GCMC strategist you act for projects within product portfolios, providing regulatory assessments and developing regulatory strategies.
* You contribute support to the Global CMC representative, within cross-functional project teams. You are accountable for assigned projects and activities, independently completing work within assigned work group/project teams, for multiple projects.
* You interprete CMC regulatory requirements, develop strategies (including novel approaches), assess risks and develops contingencies. You use technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation.
* You are responsible for the development of CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control.
* You are able to collaborate effectively across a network of other stakeholders, partners and customers, to deliver high quality CMC submissions and ensuring the compliance of the Pfizer biopharmaceutical portfolio. You manage the resolution of regulatory CMC/information management issues with project/program stakeholders.
* You are able to develop and/or lead projects or team initiatives to support short-term operational goals and contribute to the development of global regulatory initiatives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Belgium - Brussels, La Plaine