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Regulatory Affairs Manager III - UK

Employer
Proclinical Staffing
Location
Maidenhead, Berkshire, England
Salary
Negotiable
Start date
22 Oct 2019
Closing date
5 Nov 2019

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Management

Job Details

An internationally known biotechnology company has an opening for a position as a Regulatory Affairs Manager III at their UK-based office. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide. The Regulatory Affairs Manager will contribute to the development and implementation of EU regional clinical and pre-clinical regulatory strategy for products post MAA approval. This is a contract position.

Job Responsibilities:

  • Leading the planning, coordination, and preparation of regulatory submissions and label development, supporting the EU Regulatory Lead for products post MAA approval.
  • Identifying and assessing regulatory risks associated with assigned projects and overall product development.
  • Assisting in defining strategies to mitigate risks.
  • Representing regulatory on project teams for assigned projects.
  • Representing the company for defined projects (as appropriate) with local and regional regulatory authorities, contractors, and corporate partners.

Skills and Requirements:

  • BA/BS/University degree is required, Life/Health Sciences preferred.
  • Minimum of 5 years pharmaceutical/biotechnology industry experience with technical management experience.
  • Minimum of 2 years in Regulatory Sciences.
  • Some EU regulatory experience managing submissions preferred.
  • Experience in interpretation of regulations, guidelines, and policy statements.
  • Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Emily Oakley-Keenan at +44 2038542469 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-EO1

#RegulatoryAffairs

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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