Senior Manager Regulatory Affairs - Oncology - Hertfordshire (Head Office)

Medical Affairs, Other

East Anglia, East Midlands, London, South East (Excluding London)

£Competitive

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Reference: 6840

* This Vacancy Has Now Expired *

A world-leading, research-based Pharmaceutical organisation are seeking a dynamic individual to take on the new role as Senior Manager in Regulatory Affairs within the Oncology division. This role will be focused more specifically around Brexit, and will be responsible for re-registering all of our clients products, and for the maintenance of the products life cycle. The successful candidate will be based at our clients Head Office in Hertfordshire.

Essential Requirements
You will possess significant experience in the Pharmaceutical industry, ideally gained within the Oncology therapy area.
Experience in regulatory methods and processes in the Pharmaceutical industry.
Proven knowledge of UK regulations including clinical trial regulations.
Ideally experience in liaising with regulatory authorities (both in writing and verbally)
Experience of Life cycle management for Centralised products, including Type I and Type 2 license variations, line extensions, negotiating labelling with regulatory authorities
Must be able to operate in a complex environment and adapt well to changes.
Current driving licence with no more than 6 points.

Role Responsibilities
Reporting into the Director and supports one of our client’s key products.
Responsible for the life cycle maintenance for these assets and providing strategic support for activities.
Represent the team with regards to these activities at project teams and at senior management updates as required.
Sets objectives, delivers results and implements policies and operational targets that have a direct impact on the work unit or operational outcome.
Contributes to the planning, execution, and assessment of product life cycle management activities and strategies.
Contributes to, and implements, strategy for interactions and negotiations with health authorities.
May autonomously handle routine communications with regulatory authorities.
Executes work procedures in a project context. Consistently exercises judgment and discretion within generally defined procedures.
Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments.
Called upon to develop solutions utilising creativity and ingenuity.
Presents concepts, facts, and reports to mid-level internal and external clients to advise of key trends and issues.
Contact with clients and external vendors and troubleshooting routine client inquiries. May represent the organisation as a prime contact for technical matters of significant complexity.
Directs the activity of a work team project within the department. May have responsibility for management of highly skilled professional employees.
Enhances the capabilities of current resources (tools, systems, vendors, etc.), technologies, and processes for the team.
May manage contractors and ensure that contractors, consultants and vendors complete assigned work according to agreed timelines.

Role Specific Competencies
Excellent written and verbal communication skills
Strong problem solving skills and eye for detail
Planning and Timely Decision Making
Priority Setting
Presentation Skills
Developing Direct Reports and Others

Recruitment Process
2 stage process.

Salary
Highly competitive package + bonus / benefits.

Evolve Selection is a leading UK recruitment and contract sales organisation (CSO), operating within the Pharmaceutical, Healthcare and Medical Device sectors. We offer a highly comprehensive range of permanent recruitment and flexible contract sales solutions.

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