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EU Regulatory Strategy Lead
1 mese fa
Job Summary
We are seeking a highly skilled EU Regulatory Strategy Lead to join our team at Pfizer. As a key member of our Global Regulatory Strategic Team, you will be responsible for developing and implementing EU regional strategies for our designated early phase Oncology portfolio.
Key Responsibilities
- Develop and implement EU regional strategies for the designated early phase Oncology portfolio.
- Oversee and contribute to the development of EU regional strategies as a member of the Global Regulatory Strategic Team.
- Lead, oversee, and/or implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals.
- Supervise EU regulatory strategists and be accountable for staff and talent development, career development and planning, and performance management.
- Accountable for timely submissions and approvals in the EU for the designated early phase Oncology portfolio.
- Accountable for ensuring optimal regulatory interactions with EU Health Authorities for programs in the designated early phase Oncology portfolio.
- Contribute to the EU Oncology Regulatory Strategy Leadership Team and drive the required culture and behaviors through the organization.
- Champion flexible approaches to ensure efficient and effective resource utilization.
Qualifications
- Advanced Scientific Degree (M.D, Ph.D, Pharm.D, M.Sc) or equivalent experience in drug, device, development, and/or commercialization.
- A business qualification (MBA) may be useful. Proven business management capabilities.
- Demonstrable experience in drug and/or device development or relevant experience in the Pharmaceutical industry, preferably in Drug Development or Clinical Research, ideally within Regulatory Sciences/Health Authority and/or proven track record of success in negotiating with Health Authorities at EU regional level and in representing interests to internal and external stakeholders.
- Relevant Global regulatory experience (more than one region).
- Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
- Proven ability to function autonomously at a senior level in a highly matrixed organization.
- Has significant experience of the oncology therapeutic area, through prior regulatory experience; direct product development and/or academic training.
- Proven ability in developing and implementing regulatory strategy - Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting CTAs, MAA.
- Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management.
- Presentation skills - Is effective in a variety of formal presentation settings; one-on-one, small and large groups, with peers, direct reports, and senior manager.
- Negotiation skills - Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations.