Senior Manager / Associate Director, Regulatory Affairs

Key People

Sorry, This job post has expired.

Job ID :

1983


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

PhD


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 :

Oxfordshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

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 tbarratt@keypeople.co.uk


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

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 www.keypeople.co.uk.

View all Key People Jobs



© 2017 Jobsinpharma - 4ward Technologies Ltd All rights reserved.