Global Regulatory Affairs Manager Cmc Gene Therapy

Beschreibung:
We make it GmbH is a company operating nationally in Switzerland, which has a high level of competence in the personnel services sector thanks to many years of successful experience.

Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest demands on quality, ethics and discretion.

For our Client who is based in Bern we are searching for a Global Regulatory Affairs Manager CMC Gene Therapy:
**Global Regulatory Affairs Manager CMC Gene Therapy**:
**Background**

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.

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.

**Task and Responsibilites**
- 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.
- 3 Responsible for strategic CMC regulatory activities related to the assigned products of the gene therapy portfolio,
including as applicable:

- Is a permanent member of the Global Regulatory Affairs Strategy Team(s) (GRAST(s)) and/or of relevant CMC
Regulatory Sub-Team(s).
- May represent Global Regulatory Affairs in Project Statetegy Teams for CMC projects and/or crossfunctional sub-teams.
- Is responsible for development and implementation of global CMC regulatory strategies for product development, clinical
the most efficient way while ensuring compliance with global regulatory requirements.
- 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. This
responsibility includes:

- Chairs the related Global Regulatory Strategy Team(s) (GRAST(s)).
- Is accountable for the regulatory contribution to successful product lifecycle management in alignment with key internal
stakeholders (e.g. Commercial, Operations, Safety).
- Leads and oversees the development and alignment of global regulatory strategies for product lifecycle management
activities within the GRAST. Ensures integration of regional regulatory requierements, adequate documentation and proactive
adaptation of strategies to ensure incorporation of new information and start-of-the-art regulatory intelligence.
- 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).

**You must have these qualifications**
- University (or equivalent institution of higher education) degree in a relevant field (Molecular Life Sciences, Process
Development). Higher postgraduate degrees, e.g. Masters or PhD, will be well regarded
- Good communication and organizational skills
- Language proficiency: near native / fluent in German and / or English. Highly proficient in both languages will be well
regarded

**Work hours**
- 41 h./ Week

**Are you interested?