Lead Regulatory Scientist - Welwyn, United Kingdom - Clearline Recruitmentment Ltd

Clearline Recruitmentment Ltd

Verified Company

Welwyn, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Job Title:
Lead Regulatory Scientist

Location:
Welwyn

Salary:
£600 - £750 per day, outside IR35

Full Time:
Hybrid 2/3 days per week in office

12 Month Contract

Our client, based in Welwyn, are a leading name in pharmaceuticals globally, who are looking to recruit a Lead Regulatory Scientist.

In this Senior regulatory role (known internally as LTO Partner:
Regulatory) you will provide strategic and technical advicewithin the department and across the business, and be responsible for regulatory management of marketed medicines in the UK and innovative development products that will be submitted post EU exit. You will mentor and coach the Regulatory Affairs team to upscaletheir strategic and technical knowledge.

Responsibilities

Support the department with preparations for Brexit.
Represent UK Regulatory Affairs (DRA) both externally, internally at EU/HQ level, and in crossfunctional teams to support the business.
Lead in interactions with national regulatory agencies on policy, scientific advice and product issues.
Give strategic and relevant regulatory input to support development and lifecycle management.
Know the brand strategies, ensuring timely communication of regulatory activities and timelines to support brand planning.
Build contacts and understanding across the business, identifying business opportunities for Regulatory Affairs.
Seek knowledge in specialist areas, interpret and communicate impact analysis within Regulatory Affairs and across relevant business areas.
Assess content of proposed national submissions, proposing solutions to correct deficiencies and ensuring high quality regulatory submissions are made and implemented in a timely manner in collaboration with colleagues to maintain compliance.
Ensure questions and commitments from our national regulatory authorities are proactively managed.
Contribute to efficiency and process improvement including development of best practices, SOP maintenance and appropriate tracking tools, templates.
Be able to coach less experienced colleagues in their work.

Requirements:

University degree or equivalent, preferably in a scientific discipline. Further education or training in Regulatory Affairs desirable.
Successful track record in Regulatory Affairs, including stakeholder management and experience of UK or EU management of Marketing Authorisations and CTAs. Experience in other aligned areas e.g. drug safety, clinical trials, discovery or development researchdesirable.
Planning and project management of large, complex activities.
Proven successful interactions with health authorities, both through face to face meetings as well as through MAA procedures.
Ability to communicate across all levels, teamwork, IT skills.
Excellent attention to detail, accuracy.

For more information, please contact Jamie Watson at Clearline Recruitment.