Director / Head of Regulatory Affairs

Key People

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Job ID :

8015


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Hertfordshire,Hertfordshire,


Key Skills :

head of regulatory, head, director, associate Director, manager, regulatory affairs, uk, ireland, af


Salary :

£75000 - £85000 per annum + car, bonus, benefits


Date Posted :

26 Jul, 2017



Company Name :

Key People


Location1 :

Hertfordshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

A rare opportunity has arisen for a Regulatory Affairs Director / Head of Regulatory to lead the UK & Ireland Affiliate team based within a Top 5 Generics company based in Hertfordshire.

Within this role you will lead a team of four people, two Senior Officers and two Principle Officers, and oversee the integration of two teams. If you have a strong background in team leadership and extensive UK/IE Affiliate Regulatory Knowledge, this role will offer you the opportunity to develop a new team, build the culture of the team and be part of a regulatory department with growing product responsibilities.

Main Responsibilities:

-To lead, develop and manage the affiliate for a generic and branded portfolio.
-To ensure that the Regulatory Function operates in line with regional regulatory objectives and working practices and supports the local commercial objectives.
-Provide strategic and operational management of products and projects working with initiative and in a proactive fashion with consideration for commercial implications.
-Accountable for the regulatory output from the affiliate team, with emphasis on quality and timeliness; and to be personally responsible for a defined portfolio of products.
-Ensure regulatory compliance of all UK, Ireland and Malta licences with relevant national and European regulatory requirements
-Lead and participate in cross functional teams to ensure that business and regulatory objectives are met.
-Develop working practices within the affiliate to ensure both compliance and statutory compliance is met.
-Maintain an awareness of the changing regulatory environment for and ensure that the impact is fully assessed within the business.
-Represent the affiliate at appropriate meetings with key stakeholders, both external and internal, including BGMA and ABPI.

Required Experience:

- TOPRA membership
-Ability to navigate sensitive issues, provide solutions and work independently
-Enthusiastic professional who can act with speed and confidence, ability to consider the needs of the team and focussing on getting the collective result.
-Desire to grow and develop with the company, to contribute to the success of the company.
-Minimum BSc in Pharmacy/Life sciences or related area.
-Previous experience of managing a team essential
-High degree of competence in the broader aspects of regulatory affairs in both branded and generic areas essential
-Experience of working in an affiliate environment desirable.
-Highly developed communication and presentation skills
-Highly developed project management skills
-Self-starter and highly motivated

For further details, please contact Tim Barratt at Key People on +44(0)1727 817 626 or email 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.

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