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Regulatory Affairs Senior Associate

Employer
Proclinical Staffing
Location
England, Uxbridge, London
Salary
Negotiable
Start date
13 Aug 2019
Closing date
27 Aug 2019

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

A leading biopharmaceutical organisation with a solid commercial portfolio of life-saving drugs within a number of therapy areas have a new Regulatory Affairs Senior Associate job opportunity at their offices in Uxbridge. The company has a growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents.

Job Responsibilities:

  • Prepare regulatory submissions for investigational and commercial products in the Respiratory/Inflammation therapeutic area.
  • Prepare and/or co-ordinate the preparation of regulatory documentation to support Clinical Trial Applications/ amendments and attend Clinical Study Management (SMT) meetings, as required.
  • Prepare and/or co-ordinate the submission of non-clinical, clinical, and safety regulatory documentation in accordance with regulations, post licensing commitments, and legal obligations of the marketing Authorisation Holder via the European Centralised procedure, e.g. variations, PSURs, RMPs, responses to questions and renewals etc.
  • Support scientific advice procedures and Paediatric Investigation Plans (PIP) in the European Union.
  • Interact with the US regulatory, Clinical Research, and Clinical Operations team leads to ensure optimal execution of the agreed regulatory strategy for development medicinal products.
  • Represent International Regulatory function at cross functional submission/study management team meetings.
  • Ensure product packaging and associated information is updated and maintained in accordance with product licenses, in international territories, including the review of artwork and the provision of accurate labelling translations.
  • Provide advice and practical input on labeling issues across the development and marketed product portfolio.
  • Maintain a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to product teams and senior management.
  • Participate in regulatory team meetings and present project status updates.

Skills and Requirements:

  • Degree in biological/life sciences, pharmacy or medicine. An advanced degree is desirable.
  • Experience in the preparation and submission of regulatory documentation to support clinical trials applications/amendments in the European Union and a good breadth of understanding of European regulations relating to clinical trials.
  • An understanding of the regulatory requirements for the EU centralized procedure, together with experience in post-licensing management of products is preferable.
  • Must be able to facilitate effective interactions within the International Regulatory Department, as well as with other departments and sites within the Company (for example, Clinical Research and Pharmacovigilance and Epidemiology), and Gilead affiliates and distributors
  • Experience representing Regulatory Affairs on cross-functional teams is desirable.
  • Able to facilitate/lead, impact and influence effective strategic planning interactions and discussions.
  • Ability to work under minimal supervision of Regulatory Affairs professionals but following detailed instruction with well-defined procedures.
  • Ability to understand and effectively relate to external and internal customers.
  • Experience with working with document management systems.
  • A good knowledge of the therapeutic area or a good scientific background and understanding with the ability to acquire this knowledge in a short timeframe.
  • 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 Alex Czuprynski at +44 203 869 2329 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical 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-AC1

#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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