Hobson Prior are looking for a Regulatory Affairs Senior Manager to join a global biopharmaceutical company where you will support one or more oncology products from a European regulatory perspective. As a member of the Global Regulatory Team, you will define the regulatory strategy and support the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.

Job Responsibilities:

• Ensure that the organisation acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products.
• Ensure timely regulatory compliance with above approvals.
• May provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade).
• Responsible for advising the GRT on regional considerations in developing strategy.
• Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
• May manage one or more regional leads or support roles Strategy and Execution Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within the organisation's portfolio in compliance with global filing plans and local regulatory requirements.
• Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
• Leads development of regional regulatory documents and meetings in accordance with GRT strategy.
• Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and pediatric plan).
• Directs the development of the regional product label by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
• Manages regional label negotiation activities.
• Participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning.
• Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives.
• Co-ordinates company responses to requests from regulatory authorities.

Key Skills:

• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.

Requirements:

• Regulatory knowledge in regional legislation Working with policies, procedures and SOPs.
• Experience with national legislation and regulations relating to medicinal products.
• Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.
• Understanding of drug development Scientific / Technical Excellence Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage.
• Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes.
• Cultural awareness and sensitivity to achieve results across both regional country and International borders.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.