As the Director Regulatory Affairs CMC, you will be responsible for the oversight of the Strategic Regulatory Services (SRS) CMC team offering strategic, technical and regulatory global CMC consulting to clients during drug development, marketing authorization (BLA) and product maintenance. You will also be responsible for growth and development of the team through business development activities.
In this role you will lead the team and also lead CMC strategy for some clients to support registration (new and maintenance) in Canada and Internationally for drugs and biologics, and be responsible for the strategic approach, facilitating issue resolution, ensuring project/program timelines/budgets are met.
Responsibilities and accountabilities:
- Serve as a resource for SRS team members and ICON colleagues, providing advice on project and Regulatory strategies.
- Utilize your technical knowledge of biologics development/manufacturing to act as a technical expert in CMC, providing technical and regulatory consulting to clients
- Provide support to multidisciplinary teams on the content, authoring and submission of a Biologics Licensing
- Application (BLA) or MAA and its regulatory review process in the life cycle management.
- Assist with the scientific writing and review of an IND/CTA application, BLA and evaluate conformance with the regulatory requirements.
- Continually monitor newly published FDA/EMA/ICH guidelines and other international guidance documents in the context of new and ongoing development programs. Provide training on applicable requirements to the teams as required.
- Manage, preparation and review of IND/CTA amendments, annual reports and other regulatory documents and their correspondences.
- Act as liaison between company and EMA/FDA other health authorities for assigned projects.
- Formulate and lead the global CMC regulatory strategy for Biologic products drawing on extensive regulatory expertise with a focus on innovation to support accelerated approval with minimum regulatory risks and compliance.
- Actively anticipate and develop initial or alternative development strategies, consulting with other resources within the organization as required.
- Provide clients with strategic advice in response to their queries, based on regulatory experience and expertise in at least one CMC discipline.
- Thorough working knowledge of local and global Health Authority regulations, guidelines, policies, GCP and GxP, ICH Guidelines
- Demonstrable technical expertise in at least one CMC discipline (analytical chemistry, organic synthetic/process chemistry, drug product formulation/process development, biologics development/manufacturing)
- Advanced degree (MSc., PhD., M.D., Pharm.D, MBA) in the biological, medical, chemical or engineering field may be beneficial.
- Minimum of 12-15 years related experience in Regulatory Affairs CMC, in Pharma or CRO
- Experience supporting business development activities and people management.
- Experience presenting at applicable industry conferences and/or publications in regulatory affairs and CMC.