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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Operations

Location: United Kingdom

The Regulatory Affairs Manager will support one or more products from a regional regulatory perspective. The Regulatory Affairs Manager will be working with cross-functional teams, including those in Development, Medical, Commercial, and Value and Access. As a member of the Global Regulatory Team (GRT), the Regulatory Affairs Manager will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.

Job Responsibilities

Advising on regional regulatory considerations in developing strategy
Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
Under general supervision, planning and managing regulatory submissions (e.g. clinical trial and marketing applications) for products within the company's portfolio in compliance with global filing plans and local regulatory requirements.
Under general supervision, developing and/or implementing innovative and compelling regulatory strategies designed to enable patient access, following regulatory affairs processes and activity planning in accordance with national legislation and regional regulatory requirements.
Under general supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
Leading development of regional regulatory documents and meetings in accordance with the regulatory strategy
Providing regulatory direction on regional regulatory mechanisms to optimise product development
Directing the development of the regional product label by collaborating with internal stakeholders to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
Managing regional label negotiation activities
Identifying and mitigating regulatory risks and support contingency planning
Acting as a contact with relevant regulatory agencies in fulfilling local obligations by product assignment
Documenting and communicating details and outcomes of regulatory agency interactions to GRT and relevant Sr. Management

Skills and Requirements

Relevant experience with regulatory activities in the EU region including clinical trials (CTAs) and registration procedures
Good knowledge of and experience in regional regulatory environment in relevant product area and development stage
Ability to anticipate regulatory agency responses to strategy
Awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development
Experience with EU and national legislation and regulations relating to medicinal products
Ability to understand and communicate scientific/clinical information
Cultural awareness and sensitivity to achieve results across both regional country and International borders

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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