Associate Director Regulatory Affairs EMEA (Oncology)

High Wycombe
14 Jan 2019
11 Feb 2019
Regulatory Affairs
Contract Type
Jenni at CK Group is recruiting for an Associate Director Regulatory Affairs EMEA to join a company in the Pharmaceutical industry at their site based in High Wycombe on an initial 12 month contract basis.

The Company:
Our client is one of the world's leading research-based pharmaceutical companies and is part of a global family of companies - the largest diversified healthcare group in the world with over 100 years of scientific heritage. They employ approximately 500 people in the UK and Ireland. They are committed to delivering great medicines and have introduced a range of innovative treatments that can make an important difference to the lives of patients with serious health conditions such as schizophrenia, hepatitis C, multiple myeloma, HIV/AIDS and diabetes.

Working at their Headquarters in High Wycombe, the site is easily commutable. The nearest station is approximately 10 minutes by taxi. If you're travelling by car you can assess the site via the M40.

The Role:
Key duties include:
Strategic and tactical input in development, post-approval and Life cycle management:
• Advise the Project Team and/or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates.
• Develop and ensure effective implementation of regional regulatory strategy and tactics in support of the global development and life-cycle management plan.
• Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area.
• Provide input for developing and updating the Target EU SmPC based on an understanding of the implications of regional regulatory strategy for labeling.

Liaison with Regulatory Agencies and Local Operating Companies:
• Establish and maintain strong relationships with Regulatory Agencies.
• Act as primary contact with EMEA.
• Prepare team, manage, conduct and facilitate contacts/meetings with Regulatory Agencies.
• Ensure that issues raised by Regulatory Agencies are promptly and adequately addressed.

Input in document and process development:
• Advise team on required documents and processes to support Regulatory Agency contacts and submission.
• Plan and develop briefing documents for meetings with Regulatory Agencies.
• Provide input to and review submission documents to ensure that they are fit for purpose and support labeling statements as appropriate.
• Define, generate and submit appropriate data-driven (regional/local) responses to Regulatory Agency questions.

Clinical Trial Applications (CTA):
• Ensure protocols are developed in alignment with regional registration strategies to support registration, reimbursement and competitive labeling.
• Advise team on required documents and submission strategies in preparation of CTA.
• Ensure CTA submission packages are complete and available according to agreed timelines.

Marketing Authorization Application (MAA):
• Provide regulatory support throughout registration process.
• Provide regulatory support throughout life-cycle management.
• Manage submissions, define submission plans, and advise team on required documents and submission strategies in preparation of MAAs (in collaboration with LOCs as appropriate).
• Ensure timely MAA availability, track critical path activities.
• Responsible for submission and acceptance of MAA.

Your Background:
To be considered for this role you should have the following education, experience, skills and knowledge:
• University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience.
• Breadth of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas).
• Experience with EU regulatory procedures (CP, MRP, national).
• Experience in working in project teams and/or a matrix organization.
• Negotiating and conflict handling skills.
• People management skills.
• Complex project management skills.
• Oral & written communication skills.
• Organization & multi-tasking skills.
• Excellent knowledge of English.
• Knowledge of the applicable therapeutic area.
• In depth knowledge of the regulatory environment, guidelines and practice of EMEA regions.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.  Please quote reference 44387 in all correspondence.

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