This position will lead the regulatory activities associated with the Chemistry, Manufacturing and Controls for licensed and clinical innovative Biologics including Cell and Gene Therapy products. This position will provide input into the product strategy and to the direction provided to commercial and clinical teams. Incumbent will provide dedicated regulatory CMC support for gene and cell therapies, be responsible for assuring the established regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality. Additional duties include coordination with our Genomics Medicines Unit, integration of regulatory strategy with our sites and communication to cross-functional teams and senior management. Regulatory knowledge regarding innovative biologics, gene- and cell-therapy development, manufacturing, and analytical testing are essential. The incumbent has a patient- and quality-focused mindset and drives a culture of continuous improvement in compliance with our behavioral and ethical standards. Experience working in a matrix environment and excellent people skills are required. Lead, supervise and coach a team of approximately 4 regulatory professionals and be responsible for their development. Provide support for other CMC projects as needed.
Major Activities/Key Responsibilities:
Leads and manages a subteam of the product range for innovative biologics, gene- or cell-therapies
Manages and supervises a sub-team in the product range and develops staff.
Contributes to strategy and planning in the product range.
Supports Global RA and Product Range objectives.
Provides senior CMC regulatory expertise and guidance
Oversees and reviews regulatory CMC strategies of the assigned team.
Participates in peer reviews of CMC regulatory strategies.
Supports development, review and alignment of cross-product RCMC positions and regulatory dossier templates.
Represents GRA CMC Biologics in internal and industry association teams to influence policy and practice on gene- and cell therapy CMC.
Acts as GRA CMC Biologics Product Focal Point for assigned products
Takes the role of the GRA CMC Biologics representative in project / product teams
Represents GRA CMC Biologics in Global CMC and Global Regulatory Team(s) and meetings, partners with the leaders of these teams to facilitate successful product development.
Provides accurate regulatory assessments and expertise input to team recommendations.
Facilitates together with the CMC teams and regional/local regulatory experts the planning and execution of regulatory actions (submissions, meetings, etc.).
Communicates project plans, status and updates to management.
Develops and executes global regulatory CMC strategy for assigned product
Gathers and assembles needed CMC source information, regulatory requirements relevant for the product, regulatory intelligence in the field.
Develops, aligns and formulates the global regulatory CMC strategy and writes strategy documentation.
Provides interpretive analyses of regulatory guidance, regulations, or directives that impact product(s) or CMC operations.
Supports CMC regulatory risk assessments, and drives contingency planning and mitigation of identified regulatory risks.
Manages global regulatory submissions and dispatches of CMC packages for new applications / maintenance-, amendment-, supplement-, response submissions etc.
Plans submissions and CMC dossier/package strategies per the product’s global CMC regulatory strategy for CTA/INDs, BLA/MAAs, international MAs, HA meetings, maintenance submissions, change amendments/supplements, commitments, etc.
Determines and gains alignment on the required content for CMC dossiers and timelines.
Coordinates and supports dossier preparation, review and publishing process in line with project timelines.
Manages regulatory databases for planning and tracking of regulatory submissions.
Manages CMC related Health Authority liaison and communication
Interacts and liaises with FDA, EMA on product and CMC topics, coordinates health authority interactions on CMC topics with international Health Authorities and together with local/regional teams.
Leads the Regulatory CMC content of meetings with FDA, EMA, supports Health Authority meetings as SME in international countries.
Communicates outcomes of health authority procedures or feedback to teams and management.
Tracks HA communication and questions/responses in regulatory databases.
Supports compliance requirements and activities
Provides CMC regulatory input to change management processes.
Ensures regulatory events are tracked in central databases.
Prepares reports on regulatory plans and status for management and development/industrial committees.
Supports dossier compliance activities, health authority inspections and internal/external audits as needed.
- University degree in a life sciences discipline, PhD or MSc preferred.
- Strong background in either of the fields of gene or cell therapy applications, genome editing, mRNA vaccination, CAR-T, NK-cell technologies.
- 10+ years experience in regulated pharma environments (research, development, manufacture or analytics) or as technical/scientific reviewer at competent authorities.
- Proven expertise / experience with developing global regulatory CMC strategies for gene- and cell therapy products, leading regulatory submissions and health authority interactions. Ideally experience with late stage development / commercial gene- or cell therapy products.
- Sound understanding of ICH and major markets’ regulations on biologics and advanced therapeutic modalities.
- Experience in managing people in either a project or functional context.
- Good understanding of the competition in the area of gene and cell therapies is preferred.
- Experience in working with industry associations and policy groups.
- Excellent organizational and communication (written and verbal) skills.
- Proficient in using digital tools (MS Word, Excel, PowerPoint, regulatory databases and document management systems).
- Previously worked in an international, matrixed, fast-paced environment.
- Previously worked with external collaboration partners and/or CROs/CMOs.