This vacancy is for a Regulatory CMC Associate job at a leading multinational biopharmaceutical company with leading therapies in autoimmune diseases and oncology. This role will be based at their offices in Middlesex, UK and is an exciting opportunity to work for one of the world's biggest biotechnology firms that is regularly included on numerous best employers' lists worldwide.
The Regulatory Professional will contribute in implementation of regional strategies by leading the execution of the preparation of CMC components of filings for one or more products according to the CMC timelines under the direction of the regional lead.
- Responsible for organization and preparation CMC documents for filings from marketing authorisation to post-approval supplements, renewals and responses to questions across all regions.
- Participate in the gathering, consolidating and analysing regulatory intelligence for all regions and support its application to product-specific activities by maintaining templates for regional requirements.
- Responsible for documenting CMC submissions and archiving documents in document management systems.
- Responsible for refining/creating select CMC procedures and systems and will be responsible for interface with regulatory operations staff.
- Authoring of redactions for use in emerging markets for all application types.
- Coordinate reviews and QC of regulatory documentation (e.g. redaction)
Education, Skills and Experience:
- Broad experience of pharmaceutical/biotechnology or medical device industry
- Specialist knowledge of Regulatory Affairs for a minimum of 1-2 years.
- Regulatory CMC experience
- Strong communication skills - oral and written organizational skills
- Understanding of drug development process
- CMC - specific regulatory knowledge & experience
- Strong interpersonal skills
- Ability to develop solutions to technical and organizational issues in order to improve performance and productivity
- Strong computer skills, including word processing, database document repository and project management software
- Strong team player with a commitment to customer service
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 Peter Duvall on +44 203 0789 542 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.