Global Program Regulatory Manager/CTA Senior Manager (MGP/SLV) REMOTE POSSIBLE
- Experience Level
- Experienced (non-manager)
Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.
We are currently looking for a Global Program Regulatory Manager/CTA Senior Manager to be based in Basel for a 6 x month contract position.
As the Global Program Regulatory Manager/CTA Senior Manager you will be working independently under limited supervision to provide strategic and operational regulatory direction and may support the DRA global program team (GPT) representative and/or GTAL for programs through development, registration and approval/post approval.
- Responsible for implementing regulatory strategy and managing operational activities for assigned regions
- Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions
- Determines requirements and sets objectives for Health Authority (HA) interactions with RA GPT representative and/or GTAL
- Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents
- Submissions and Approvals:
1. Implements strategy across regions in line with global strategy.
2. Identifies issues, gaps, and trade-offs affecting optimal and timely submission and approval.
3. Proposes options to minimize risk.
4. Drives coordination, planning, and submission of dossiers in assigned regions worldwide.
5. Review of global dossier summary documents.
- Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) with RA GPT representative and/or GTAL, consistent with development data and commercial objectives of the TPP.
- Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data:
- 2. Identification of main HA issues for Seed Document
- 3. Participation in relevant Regulatory Boards leading to valuable input from these Boards
- 4. Successful participation in HA interactions to achieve business objectives
- 5. Provides comprehensive regulatory feedback to achieve global business objectives
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required;
- Bachelor/Advance Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
- Global Regulatory experience and experience in drug/biopharmaceuticals
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology.
- Extensive knowledge of the drug development process
- Ability to critically evaluate data from a broad range of scientific disciplines
- Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable
- Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload
- Effective planning, organizational and interpersonal skills
- Excellent written/spoken communication and negotiation skills
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