Senior Manager / Associate Director, Regulatory Affairs

Key People

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :


Address 1 :

United Kingdom,Oxfordshire,Oxfordshire,

Key Skills :

regulatory manager, manager, regulatory affairs, associate director, director, senior manager, post

Salary :

£70000 - £80000 per annum + bonus, car allowance and share scheme

Date Posted :

04 May, 2016

Company Name :

Key People

Location1 :


Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:



An excellent opportunity has arisen for a Senior Manager / Associate Director of International Regulatory Affairs to join a leading Pharmaceutical company based in Oxfordshire / Berkshire. Within this role you will be responsible for EU/ROW regulatory activities and direct the company's regulatory affairs activities and initiatives. You will help lead regulatory efforts in order to obtain worldwide approval of the company's products and oversee a team of regulatory professionals.

Job Responsibilities:

*Develop and implement International regulatory strategies to facilitate the progress of programs in all phases of development
*Serve as the Regulatory Affairs representative on project teams and assure the progress of projects by providing direction, solutions and feedback to the teams
*Lead interactions with regulatory agencies for your projects and products
*Lead preparation and support review of CTAs, BLAs and MAAs in different regions around the world, including CMC, nonclinical, and clinical activities
*Support the company's commercial products
*Interact with Regulatory Affairs personnel at partner companies
*Establish and meet timelines for regulatory submissions
*Maintain awareness and communicate with team members regarding changing regulatory requirements

Minimum Requirements:
*Bachelors or Masters or advanced degree in a scientific discipline, with a minimum of 8 years of increasingly responsible regulatory experience in the biopharmaceutical industry
*Deep and broad knowledge of worldwide regulatory affairs; direct experience with pharmaceutical regulatory submissions and product approvals worldwide
*A proven track record of effective collaboration with regulatory agencies
*Demonstrated leadership success in management, including building and/or leading a regulatory affairs team or department
*Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions
*Ability to work with minimal supervision, to set priorities to meet timelines, to motivate others, and to manage budgets
*Some travel required

For further details about this role or other opportunities within Regulatory Affairs please contact Tim Barratt on +44 (0) 1727 817 626 or email a copy of your CV to

Company Name:

Key People


Catherine House,Adelaide Street


Staffing Firms


United Kingdom





less than 100




St Albans

Phone No. :

01727 817 626

Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit

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