Vacancy Detail

Regulatory Affairs Manager


Region: South Central

Location: Berkshire

Salary: Competitive

Ref: 04569

Job Type: Permanent

Posted: 17/02/2021

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Regulatory Affairs Manager


Role description

Role: Regulatory Affairs Manager
Location: Head Office, Berkshire
Therapy Area: Diabetes and Cardiovascular
Salary: Negotiable highly competitive salary depending on experience, bonus, company car and additional package benefits

Role Type: Regulatory Affairs, Regulatory Affairs Manager
This is an exciting opportunity to work as a Regulatory Affairs Manager with responsibility to manage a team of Regulatory Affairs Officers and work within a matrix environment in which to best support the companys regulatory considerations. The role has 2 x Line reports (RA Officers) and reports to the Head of Regulatory Affairs.
In this role you will have responsibility for managing an existing product portfolio where you will develop and maintain a comprehensive understanding of EU regulatory requirements for marketing authorisations and their application in the UK and Ireland, to enable regulatory submissions to be compiled in line with current requirements. Proactively review critical new legislation and guidance documents and disseminate to relevant parties information of importance to the business.
If you are a Regulatory Affairs professional and would like to join us and make a difference, please apply!

Key Responsibilities:
Manage the review, preparation, submission and follow-up of regulatory submissions to the UK and / or Irish regulatory authorities, to high standards, to ensure that marketing authorisations are maintained in line with the companys plans and goals.
Develop strategic partnership with the Multi Country Organisation (MCO) Global Business Units to understand their priorities and align regulatory objectives of the MCO regulatory team to support the business. Attend Leadership meetings as required.
Provide strategic input into development of lifecycle strategies for Marketed Portfolio & Strategy Management (MPSM) products, both locally and in conjunction with GRA.
Input into review of promotional and non-promotional materials from a regulatory perspective, as required.
Assist the Head of Regulatory Affairs in developing strategies to optimise the efficient running of the department and to manage the achievement of appropriate registrations. Identify issues which may impact on project timeframes.
Manage the workload and personal development of staff. Supervise and train other regulatory staff within department as required by the Head of Regulatory Affairs.

The client:
Empower Life Everyday.
Working across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. With the capabilities and resources to support your aspirations to fulfil your ambitions and be the best you can be.
The company purpose is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global, and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we are not there to try to solve everybodys problems. We want to focus on those areas where we know we are making a difference.


Qualifications

Educated to degree level or equivalent, preferably with a science background Full UK Drivers Licence

Person experience required

Proven success in achieving regulatory approvals in the UK and /or Ireland. UK Submission experience with the focus on Brexit challenges Additional experience in the pharmaceutical industry in a related field is an advantage. A record of proven success in managing and supervising staff. Ability to manage multi-functional projects, and to assess detailed scientific information from a variety of disciplines. Good organisational skills and ability to manage multiple projects/priorities under pressure and to cope with tight deadlines. Ability to foresee and respond to potential problems and opportunities. Self-motivated with strong verbal and written communication skills. Ability to communicate effectively and efficiently with other functional departments in the business. Good knowledge of the development process for medicines, and capable of critically reviewing and integrating scientific information from a variety of disciplines. An understanding of biosimilars and medical devices.
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