PE Global
Senior Manager Regulatory Affairs
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PE Global is currently recruiting for a Sr Manager Regulatory Affairs for a leading multi-national Biopharma client based in Uxbridge/Cambridge.
This is an initial 12 month contract position Inside IR35. The position is hybrid. Onsite meetings once a month.
Pay rate £48.33ph PAYE or £65.68ph Umbrella.
Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in the UK
Duties of the role/Responsibilities
- 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).
- 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.
- 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 with minimal supervision, participate in the development and execution of regional regulatory product strategies.
- Estimate the likelihood of regulatory success based on proposed strategies.
- Communicate and ensure alignment of regional management before GRT strategy decisions.
- Manages core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy.
- Provides managerial leadership & direction to assigned team allowing appropriate prioritization of resources to achieve goals.
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Education/Experience
- Regulatory knowledge in regional legislation.
- The ideal candidate should have practical, hands on experience of CTR, reviewing study protocols and highlighting any regulatory risks, preparation of the clinical trial application, responding to questions.
- The role requires someone with all round experience of all aspects of the product life cycle to be able to contribute to a variety of projects.
- Working with policies, procedures and SOPs.
- Therapy area: oncology.
- 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.
- 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.
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
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Interested candidates should submit an updated CV.
Please click the link below to apply.
Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in the UK
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