Senior Regulatory Affairs Associate - ATMP
ProClinical is advertising a vacancy for a Senior Regulatory Affairs Associate - ATMP position with a leading pharmaceutical research company. The organization prides itself on its solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs and an unmatched patient access program. Based in the company's UK office, this is an exciting opportunity to work with an internationally renowned company and support their innovative impact on the healthcare field.
- Working with the European regulatory product lead for a development product and preparing regulatory documentation in accordance with Regulations, guidance and legal obligations.
- For the development product preparing and/or co-ordinating the regulatory documentation to support clinical trial applications and amendments, in the European Union.
- Working with the European regulatory product lead to ensure when licensed the product packaging and associated information is updated and maintained in accordance with Marketing Authorisation, including the review and management of labelling translations and artwork.
- Interacting with the Regulatory, Clinical Research, Clinical Operations, and other functions to ensure optimal execution of the agreed regulatory strategy for development medicinal products.
- Representing the International Regulatory Affairs function at cross functional submission and study management team meetings.
- Maintaining a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to product teams.
- Supporting the Associate Director as required.
Skills and Requirements:
- Degree in biological or life sciences, pharmacy or medicine (or international equivalent). An advanced degree is desirable or equivalent relevant experience.
- Experience in the preparation and submission of regulatory documentation to support centralised MAA procedure and post approval activities and a good breadth of understanding of the European regulations.
- Knowledge and experience relating to clinical trials would also be desirable.
- Experience representing Regulatory Affairs on cross functional teams is desirable.
- Ability to work under minimal supervision of Regulatory Affairs professionals but following detailed instruction with well-defined procedures.
- 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.
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.
£0.00 - £40000.00 per annum
An exciting opportunity has arisen for a Regulatory Operations Associate II to join a global biopharmaceutical company based in West London.
ProClinical have a new vacancy at a pharmaceutical company that specialises in the research and development of highly effective and innovative medications
Durham, North Carolina
ProClinical is currently recruiting for a Regulatory Labeling Associate position on behalf of a top 10 global pharmaceutical company.
ProClinical is advertising a vacancy for a Regulatory Operations Associate position
Swiss Franc0.00 - Swiss Franc150000.00 per annum
ProClinical is advertising a vacancy for an Associate Director of CMC Biologics position
ProClinical is advertising a vacancy for a Regulatory Affairs Associate
ProClinical is advertising a vacancy for a Regulatory Associate (Animal Health) P1 Equivalent position
£0.00 - £18 per hour
ProClinical is advertising a vacancy for a Junior Regulatory Associate
ProClinical is advertising a vacancy for an Analytical Chemist position
ProClinical are advertising a Senior Regulatory Affairs Director vacancy