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About the position
The Global Regulatory Affairs CMC department is responsible to oversee all relevant regulatory CMC aspects in each portfolio of products. The role of GRA CMC Manager / Senior Manager is part of a global team responsible for the plasma-derived products within the Immunology and Immunoglobulins therapeutic area. She/he is responsible for the CMC lifecycle management of the multiple licenses of the plasma-derived products and to support the worldwide registration of established products. The position holder will collaborate with internal and external stakeholders and interface with Research and Development, Global Manufacturing and Global Quality.
Responsibilities
- Develops and executes global regulatory strategies in close collaboration with quality, manufacturing, research and development departments to support clinical trials, NDA/MAA and post-approval phases.
- Leads regulatory teams for CMC projects / programs to align global strategies with regional regulatory requirements.
- Represents the Global Regulatory Affairs function GRA CMC in cross-functional project teams.
- Responsible for the content of regulatory submissions worldwide, meeting appropriate standards and content requirements.
- Prepares, revises, and reviews CMC relevant CTD narrative for lifecycle management submissions according to agreed timelines and taking regional regulatory requirements into account.
- Plans, coordinates, and contributes to the compilation of responses to Health Authority questions in collaboration with the relevant subject matter experts and according to the schedule agreed in the regulatory team.
- Provides regulatory contribution to annual product quality reviews and risk assessments.
- Drives storyboard, Health Authority meetings requests and background information documents, contributes to the preparation, and participates at Health Authority meetings related to assigned projects / programs.
- Compiles CMC documentation or coordinate the compilation of documents in close collaboration with subject matter experts in preparation of Health Authority meetings.
- Evaluates the available technical and scientific CMC information for compliance with regulatory requirements, performing gap analysis and proposing solutions and strategies to remediate risks.
- Provides regulatory support during international Health Authority inspections.
- Provides support to conduct compliant regulatory assessment of changes.
Requirements
- Master, advanced degree in a Life Science discipline (PhD, PharmD) is preferred.
- A minimum of 3 years regulatory experience in the pharmaceutical industry.
- Biologics regulatory experience is an advantage.
- Good knowledge of pharmaceutical drug development, and CMC regulations / guidelines governing the development and the lifecycle management of pharmaceuticals / biotechnology products.
- Excellent communication, project management, planning, problem solving and presentation skills.
- Ability to work with minimal supervision, with sound technical judgment and analytical skills.
- Flexibility to work in a global regulatory cross-cultural work environment, independently as well as in a team.
Benefits
- Excellent income potential and extended benefits
- Two additional leave days for your personal wellbeing
- Family services such as psychological support, legal advice, family care services and more for you and your direct family
- Hybrid working models
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