My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Senior Regulatory Project Manager for Western Europe Area to be based in their offices in Berkshire on an initial 12 month contract.
Design and implement Area & Affiliate regulatory strategies and deliverables for a portfolio of compounds, typically late development or marketed, for the Western Europe Area (including Israel, Turkey and Switzerland) in alignment with the overarching global regulatory strategy and region specific requirements.
- Identify and advocate region's requirements in the overarching global regulatory strategy; develop risk assessments of the project(s) and make sure taken into account at the Global Regulatory Product Team.
- Represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the GRPT, to ensure those are met. Duly report on activities in these teams and alert TA Head when necessary.
- Elaborate a local Regulatory Plan in collaboration with the RA personnel in the affiliates to define the region's position on specific projects.
- Primary RA interface with Commercial. Represent RA on the Brand Teams (provide strategic input for registration, ensure the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations, assess probability of success for submission, approval and launch by country and product).
- Primary interface to and from the RA personnel in the affiliates and local HA.
- Responsible for direct liaison with EMA for assigned products within the Therapeutic area. Receives delegation to manage EMA meetings and other agency key meetings in liaison with affiliate regulatory managers.
- Assess scientific data provided by specialist units for regulatory purposes against WE regulatory requirements, identifying gaps and developing mitigation strategies. Ensure effective presentation of data, and complete and timely responses (including CTAs).
- Maintain an active awareness of EU legislation and assess its impact on internal business and R&D programmes jointly with RI. Develop and execute strategies to respond to those. Propose revisions. Ensure application of policies once established.
- Implement the EU processes to achieve local HA input into R&D Programmes and regulatory approval.
- Provide Area input on local implications through participation in Teams as needed (e.g., submission and labelling teams).
- Ensure regulatory compliance within WE for the assigned compounds/products. Implement remediation plan to address identified gaps, if any.
- At least 10 years' experience in EU Regulatory Affairs and experience of working with Israel, Turkey and Switzerland).
- A Degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@srgtalent.com or +441753 589673
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