Global Regulatory Affairs Manager CMC Gene Therapy (remote)

On behalf of our client, an international Biotechnology company based in Bern, Swisslinx is looking for a Global Regulatory Affairs Manager CMC Gene Therapy. This is a 6-months contract position (extension possible) with a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment.

- Start date: 03/10/2022
- Duration: 6 months
- Extension: possible
- Work location: Bern (possible to work remotely)
- Workload: 100%

The GRA CMC Manager Gene Therapy is responsible for CMC regulatory activities related to product development, registration and license maintenance for the assigned products of the gene therapy portfolio.

About the role:

GRAST member/Member in regulatory CMC/crossfunctional subteams. As a member of the Global Regulatory Affairs Strategy Team GRAST and/or of relevant CMC Regulatory Sub-Team, he/she develops and implements global CMC regulatory strategies regarding product development, clinical trial applications, new license applications, product changes and relevant CMC projects related to the assigned products of the gene therapy protfolio.

For established products which are no longer in clinical development the GRA CMC Manager may be appointed as Global Regulatory Lead. In this role, he/she will chair a GRAST and be accountable for successful product lifecycle management.

- Responsible to work in an efficient, productive and harmonized fashion to be the CMC regulatory subject matter expert for the assigned tasks and activities
- Contributes to the development of global regulatory processes in agreement with her supervisor. Interprets existing or new regulatory requirements, evaluates draft guidelines and writes impact assessments
- May provide technical guidance to GRA CMC Scientists and/or Specialists and support them for organization and prioritization of submission activities. If required, deputizes for the GRA CMC Team Lead Gene Therapy

Responsible for operational CMC regulatory activities related to the assigned products and/or intermediates, including as applicable:
- Maintenance of the content of relevant parts of the regulatory dossiers
- Preparation, revision and review of Module 2.3, Module 3, required facility and equipment information and related documents for new product registrations (e.g. MAAs, BLAs) and lifecycle submissions according to agreed timelines and taking regional regulatory requirements into account. This may include technical authoring of dossier narratives and other regulatory CMC documentation
- Timely provision of high quality responses to CMC related Health Authority questions
- Compilation and review of CMC information for CTAs, INDs and other regulatory submissions related to product development (e.g. CMC documentation for Scientific Advice Meetings, Briefing Books, IBs)
- Provision or support of timely and compliant regulatory assessments as well as efficient execution of CMC changes
- Preparation and review of CMC related information and documentation required for tenders, PSURs, DSURs, CCDS/product information and promotional materials
- Regulatory contribution to annual product quality reviews and risk assessments
- Is the primary GRA contact point interfacing with relevant technical expert departments for project planning purposes, compilation and updates of technical documentation and for addressing CMC regulatory questions
- Evaluates the available technical and scientific CMC information for compliance with regulatory requirements, performs gap analysis and proposes solutions and strategies to remediate risks
- Supports scheduling and prioritization of CMC related submissions
May be appointed as Global Regulatory Lead for established products which are no longer in clinical development.• Coordinates and tracks compilation of regulatory documentation required to support new product registrations and relevant lifecycle submissions (e.g. renewals) within the GRAST
- Oversees scheduling and prioritization of all regulatory submissions for the assigned products
- As required, presents regulatory strategies, risk assessments and mitigation proposals to senior review committees such as GRA Therapeutic Areas (GRA TA Teams) or Global Lifecycle Review Board (GLRB)

For further information or to apply please do not hesitate to contact Alina Peeva, recruiter: alina.peeva@swisslinx.com
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