Regulatory Affairs Associate Director
An international pharmaceutical company is recruiting a Regulatory Affairs Associate Director to join their office in the UK. This organisation specialises in developing new approaches to address contemporary health issues, from life-threatening illnesses to chronic conditions. This is an exciting opportunity to work with a dynamic and innovative company that co-designs health solutions around their innovative medicines for complex diseases which improve standards of care.
- Define and implement Area & Affiliate regulatory strategies & deliverables for a portfolio of Oncology / Haematology compounds (early development, late development, marketed) for the Western Europe Area (including Israel, Turkey and Switzerland). Include fair representation of the interest of EU countries of EMEA.
- Identify and advocate region's requirements in the overarching global regulatory strategy; and make sure it is taken into account at the Global Regulatory Project Team (GRPT).
- Primary Regulatory Affairs (RA) interface with Commercial and in collaboration with the Regulatory Affairs personnel in the affiliates.
- Primary interface to and from the Regulatory Affairs personnel in the affiliates.
- Define and implement regulatory strategies, risk assessment & deliverables for early, late development compounds and marketed products in the Oncology / Haematology Therapeutic Area for the Western Europe Area (including Israel, Turkey and Switzerland).
- Identify and advocate region's requirements in the overarching global regulatory strategy; develop risk assessment of the project(s) and make sure it is taken into account at the GRPT.
- Represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the GRPT to ensure those are met.
- Duly reports on activities in these teams and alerts Therapeutic Area Head when necessary.
- Develop a Regulatory Strategic Tactical Plan (RSTP) in collaboration with the RA personnel in the affiliates.
- Coaches and mentor's regulatory professionals (typically project manager and senior project manager). Transfers knowledge to the Therapeutic Area.
- Primary RA interface with Commercial lead/s. Represents 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.
- Primary interface with local health authorities (via RA personnel in the affiliates).
- Responsible for direct liaison with EMA for products within the Therapeutic area. Manage EMA meetings and other agency key meetings in liaison with affiliate regulatory managers. Receives delegation to manage EU agency hearings.
- Provide leadership and support to RA personnel in the affiliates (through ongoing communication, assist in the development, training and mentoring of regulatory leaders).
- Assess scientific data provided by specialist units for registration purposes against Western Europe regulatory requirements, identifying gaps and developing mitigation strategies. Ensure effective presentation of data, complete and timely responses (including Clinical Trial Applications).
- Maintain an active awareness of EU legislation and assess its impact on the business and R&D programmes jointly with Regulatory Policy & Intelligence team. Develop and execute strategies to respond to those. Propose revisions. Ensure implementation of policies once established.
- Manage the EU Regulatory processes to achieve HA input into R&D Programmes and regulatory approval.
- Provide input on EU, Swiss, Israeli, Turkish local implications through participation in Teams as needed (e.g. submission teams, labelling working group: development of labelling negotiations).
- Ensure regulatory compliance within Western Europe for assigned compounds/products.
- The incumbent's decisions can affect sales, marketing, supply chain and clinical trials.
- The incumbent's decision can affect company's image and credibility towards regulatory agencies.
Skills and Requirements:
- Extensive pharmaceutical industry experience in European Regulatory Affairs.
- European regulatory experience (including Israel, Turkey and Switzerland).
- Significant prior experience in leading regulatory activities at early, late development stages and marketed oncology and haematology biopharmaceuticals in Europe.
- Experience working effectively across diverse cultures and in complex matrixed environment.
- Proactive verbal and written communication style at all levels.
- Strong leadership presence and solution driven style.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Roberto Esposito at 0203 761 5702 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
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