Position summary :
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, may act as CMC liaison with regulatory authorities to discuss and define submission contents and strategies.
Leads the preparation of CMC information for submission to EU regulatory agencies, generates CMC strategies, assesses risks and develops contingency plans. Ensures that CMC regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements.
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, may act as CMC representative in formal meetings and teleconferences with regulatory authorities.
Act as the EU CMC representative and contributes 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.
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.
May operate independently to resolve complex issues and manage regulatory risks and ambiguous situations within project teams. Investigates opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems.
Creates / contributes to the development of internal policies, processes and procedures supporting the progression and maintenance of the biopharmaceutical portfolio at large. Leads document management and information management teams, within Global CMC / groups outside Global CMC.
Serves as a EU GCMC strategist for projects within product portfolios, providing regulatory assessments and developing regulatory strategies.
Acts as the EU CMC representative and contributes support to the Global CMC representative, within cross-functional project teams. Accountable for assigned projects and activities, independently completing work within assigned work group/project teams, for multiple projects.
Interprets CMC regulatory requirements, develop strategies (including novel approaches), assess risks and develops contingencies. Uses technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation.
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.
Ability to collaborate effectively across a network of other stakeholders, partners and customers, to deliver high quality CMC submissions and ensuring the compliance of the biopharmaceutical portfolio. Manages the resolution of regulatory CMC/information management issues with project/program stakeholders.
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.
Education and Experience :
Scientific degree in a relevant subject (minimum PharmD or science related BSc or MSc)
An experienced regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development and/or biopharmaceutical manufacturing and/or specific regulatory domain (3-5 years prior international regulatory with experience in CMC or in Quality Assurance).
Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned projects.
Candidate is required to have a broad functional knowledge of pharmaceutical sciences / the Biopharmaceutical industry, with a clear understanding of drug development/commercial manufacturing of biopharmaceuticals.
Candidate is required to have a recognized demonstration of
• Leadership skills, influencing and persuading skills
• Excellent cross-cultural awareness and understanding
• Fluency in the English Language is essential
• Strategic thinking and decision making
• Excellent communication, interpersonal and relationship building skills
• Collaborative team player
• Excellent planning, organizational and project management skills
• Proactive and flexible
Problem solving skills to propose and assess regulatory solutions to CMC issues and prepare contingency plans will be helpful. Experience in medical device development and registration is useful.
Technical skills :
Technical and scientific understanding of biopharmaceutical drug development with technical writing skills. May serve as Subject Matter Expert in specific relevant disciplines or recognized as a regulatory CMC resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains.
Competent working knowledge of computer based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum). Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to train and support others in system use.
Contact: [email protected]