R&D Project Operations Specialist - GRA CMC Manager Gene Therapy
Skills: Regulatory Affairs, Research & Development
Global Regulatory Affairs Manager CMC Gene Therapy
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.
GRAST member/Member in regulatory CMC/crossfunctional subteams As a permanent member of the Global Regulatory Affairs Strategy Team(s) (GRAST(s)) and/or of relevant CMC Regulatory Sub-Team(s), 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 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.
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.
GRAST member/member in regulatory CMC/crossfunctional subteams 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 (eg 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 (eg 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.
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, trial applications, new license applications, product changes and relevant CMC projects with a view to reach approvals in the most efficient way while ensuring clinical 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 (eg 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 requirements, adequate documentation and pro-active 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 (eg 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).
University degree in natural sciences (BS/BA/MS or equivalent), a degree in Regulatory Affairs is advantageous.
• Minimum of 5 years' experience in the biotech or pharmaceutical industry, with at least 3 years in Regulatory Affairs.
• Sound knowledge in natural sciences with a focus on biological medicinal products.
• Basic knowledge of the regulatory framework in at least one key region (US, EU, Japan, CH, Australia).
• Excellent communication, project management, planning, problem solving and presentation skills.
• Strong team player with a demonstrated ability to develop constructive and effective relationships with peers and management.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to work with minimal supervision based on sound technical and analytical judgment.
• Flexibility to work in a global cross-cultural work environment.
• Microsoft Office skills.
• Fluent in English and local language.