ProClinical is seeking a Regulatory Affairs Manager / Senior Manager for a Biotechnology/Biosimilar organisation, to focus on regulatory strategy for their small but profitable portfolio. This will focus on the MAA for the existing licences and assisting with bringing the development pipeline through in conjunction with the development teams.
You will have a significant background in biotechnology/biogeneric post-marketing regulatory affairs including MAA complex variations as well as an understanding of the regulatory landscape. This is an exceptional opportunity to work for an outstanding first in class employer and develop your career in a positive and progressive manner.
- Involves in leading and maintaining global product registration strategy and planning including initial and product life cycle management
- Provides EU regulatory intelligence, strategic regulatory insight
- Provides support on identifying opportunities and risks, and mitigations
- Provides support on management of the office.
- Provides regulatory support to cross functional project teams for regulatory issues and questions and ensures that regulatory requirements are addressed
- Provide support on preparing and reviewing core dossier
- Provides support for major market regulatory approvals.
- Provides post-market support and ensure regulatory compliance of market-released products.
- Works closely with relevant functional teams to provide strategic regulatory guidance
- Establishes and maintains good working relationship with regulatory agencies including EMA and industry regulatory groups in European region
- Supports reviewing labelling/artwork etc. to ensure compliance with regulatory requirements
- Provides value-added support to improve team standard operation procedures by authoring new SOP or editing existing SOP
- Supervise and trains junior level employees
- Works as a liaison and/or regulatory representatives to the regulatory authorities including EMA, industry association and partner companies in European region for the assigned projects/matters.
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 call David Nixon on +44 203 078 9544 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.