Associate Director, Regulatory Affairs for Western Europe - Oncology
Competitive Salary + Excellent Benefits (Bonus, Car Allowance, Medical etc.)
Permanent, Berkshire Based
My client are a Global Pharmaceutical Organisation, has opened a new vacancy within their Regulatory team and is looking to recruit an Associate Director Regulatory Affairs for Western Europe Area.
Define and implement Area & Affiliate regulatory strategies & deliverables for a portfolio of compounds (early development, late development, marketed) for the WE Area (including Israel, Turkey and Switzerland). Include fair representation of the interest of EU countries of EMEA.
- Define and implement regulatory strategies, risk assessment & deliverables for early and late development compounds and marketed products in the assigned Therapeutic Area for the WE Area (including Israel, Turkey and Switzerland).
- Identify and advocate region's requirements in the overarching global regulatory strategy; develop risk assessment of the projects.
- Represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the Global Regulatory Product Team to ensure those are met. Duly reports on activities in these teams and alerts TA Head when necessary.
- Develop a Local Regulatory Strategic Tactical Plan (L-RSTP) in collaboration with the RA personnel in the affiliates. (Area Regulatory Product Team ARPT) to elaborate the region's position on specific projects.
- Primary RA interface with Commercial. Represent RA on the Brand Teams.
- Provide Area input on local implications through participation in Teams as needed (e.g., submission teams, labelling working group: development of labelling negotiations).
To be considered for this Associate Director RA for WE vacancy, you will need the following skills and experience;
- Extensive pharmaceutical industry experience in Regulatory Affairs with European experience and experience in the oncology area coupled with strong therapeutic area knowledge.
- A Degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.
Key Words "Regulation, Regulatory, Regulatory Affairs, Associate Director, Director, Oncology, Western Europe, Submissions, risk assessment, therapeutic area, strategic, CTA, team management, team, affiliates, processes, projects, products, pharmaceutical, registration, compliance, approval, product, commercial, interface, Berkshire"
Please apply online or call Darren Beckinsale on 0203 0964713 for more information
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