Head of Regulatory Affairs - Welwyn, United Kingdom - Clearline Recruitmentment Ltd

Clearline Recruitmentment Ltd

Verified Company

Welwyn, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Job Title:
Head of Regulatory Affairs

Location:
Welwyn (Hybrid, 2-3 days in office per week)

Salary:
£110-£120 per hour (UMB)

Full Time

6-month contract inside IR3- high potential for permanent extension

Our client is a leading name in the pharmaceutical industry globally, who are looking to hire a Head of Regulatory Affairs to join their team on 6-month contract basis.

Responsibilities

Aligning their personal purpose to the Organisational North Star to enable them to flourish and shine in their role
Utilising their skills and capabilities, and working flexibly as part of empowered, selfmanaged, multiskilled teams (where appropriate), to ensure Foundational work (where applicable) and Squadprioritised work is delivered in line with Organisationalprinciples
Working collaboratively and sharing expertise across the organisation to remove silos and duplication, ensure efficient use of similar skill sets, and to ultimately support common pursuit of the North Star
Acting as a guardian for high standards of compliance, ethics, and safety; putting patients at the centre of all actions by consistent business behaviour that complies with applicable laws, industry codes and Roche's Code of Conduct.
Contributing to resource planning/sharing across Chapters to ensure Chapters are fully resourced to meet evolving priorities of the Organisation and Customers, and any resource constraints are constructively flagged, with a collaborative approach to findsolutions (for example, by working outside of their "home" Chapter capabilities to enable greater flexibility and fluidity of Organisational resourcing)
Where applicable, ensuring "Foundational work" is completed, with continual review of _how_ it's done to drive efficiency and minimise resource required to do it (without compromising on necessary standards)
Ensuring ruthless prioritisation to avoid Chapter "workcreep" outside of Foundational work, Squadprioritised work and Personal Development.
Involvement in Squads and Squad work (Affiliate or others) and Global activities, as required
Owning their development to ensure they are continually growing skills and capabilities within their Chapter (and where appropriate, in other Chapters) in line with their passion and the needs of the Organisation (present and future)
Increasingly demonstrating VACC (Visionary, Architect, Catalyst, Coach) roles, as they develop their personal skills and capabilities, to positively support colleagues

Requirements:

Take accountability to maximise the regulatory departments value to the business in support of the development, marketing, and sales of Roche products.

Helps to shape the regulatory environment through active collaboration with external partners such asABPI and MHRA. Takes responsibility for providing strategic UK regulatory advice to business partners and global regulatory teams (PDR/PTR). Represents Regulatory Affairs to address policy matters and critical product issues with national regulatory agencies.

Ensure appropriate prioritisation, oversight & resource allocation to meet expected regulatory requirements and to ensure compliance with global Roche and local regulatory requirements for all areas of responsibility.

Possess a breadth of expertise in Regulatory Affairs with successful regulatory leadership experience in the pharmaceutical or biotech industry required.

Extensive knowledge of drug development, regulatory science, and regulatory requirements (UK and EU).University degree in a scientific/technical discipline is required, with a higher degree preferred.

Experience in aligned disciplines such as safety & pharmacovigilance, clinical research and/or medical affairs desirable.

**For more information, and a full job description, please contact Chloe McCausland at Clearline Recruitment.