Regulatory Affairs Professional
22 ore fa
**About the Role**
Pfizer is seeking a highly skilled Regulatory Affairs Professional to join our team in the Early Phase Oncology department. This role will be responsible for ensuring timely submissions and approvals in the EU region, as well as providing regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST).
Key Responsibilities
- Lead and implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with company goals.
- Accountable for ensuring optimal regulatory interactions with Health Authorities, in relation to the designated early-stage oncology portfolio within the EU.
- Partner with project teams to ensure required regulatory contributions (CTA, etc.) meet business needs and are provided to the project teams, to agreed time and quality standards.
- Develop and maintain constructive working relationships with Health Authority contacts in the EU region.
- Collaborate with GRS colleagues and relevant project team members to provide an EU position.
- Ensure alignment with GRL and early phase Oncology Global Head.
Requirements
- A scientific degree with a higher degree being an advantage but not essential.
- Proven experience in managing national and/or EU regulatory process and registration aspects of the drug development process, particularly clinical trials experience at least in one country.
- Previous experience as a national and/or EU regulatory liaison for at least one product in different therapeutic areas and in different stages of the product life cycle is highly desirable.
- Equivalent experience, either at a regulatory agency or working on substantive industry-government collaborations, can be considered.
- Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.
- Proven ability in developing and implementing regulatory strategy.
What We Offer
We offer a competitive salary of $120,000 per annum, along with a comprehensive benefits package that includes health insurance, retirement savings plan, and paid time off. If you are a motivated and experienced Regulatory Affairs Professional looking for a new challenge, please submit your application.
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