ProClinical is currently recruiting for a Senior Associate Regulatory Affairs job at a leading multinational biopharmaceutical company with leading therapies in autoimmune diseases and oncology. They are seeking an individual to bring solid regulatory affairs experience their team at their offices in the UK. This is an exciting opportunity to work for one of the world's biggest biotechnology firms that employs over 17,000 staff globally.
The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.
- Assist Regional Regulatory Lead to support regional regulatory pre-filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing, regulatory authority meeting preparations)
- Provide and maintain CTA/MA documentation support (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
- Create and maintain product regulatory history documents through IMR/rRISE and appropriately archive all regulatory documents and agency communications
- Review regional component of the Global Regulatory
- Plan and provide input to operational deliverables
- Ensure compliance via timely submissions to regulatory agencies
- Support RRL in review of promotional materials for commercial activities (ex-US)
- Collaborate with CROs / partners to support site initiation
- Coordinate collection of functional documents in support of regulatory applications
- As appropriate participate in GRT to support execution of regulatory strategy
- Coordinate QC of regulatory documentation (e.g. briefing packages)
- Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
- Prepare regulatory packages and cross-reference letters to support investigator initiated studies
- Approve drug shipment for the company and Investigator Initiated Studies
- Complete regulatory forms to support agency communications (E.G. EudraCT,)
- Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams
- Support process improvement initiatives, standards development, and metrics
- Assist in template development and maintenance
- Respond to specific requests from and communicate relevant issues to GRT Develop Regulatory
Education, Skills and Experience:
- Doctorate degree and 1 year directly related experience OR
- Masters degree and 18 months-3 years of directly related experience OR
- Bachelors degree and 3 years of directly related experience
- Experience supporting regional regulatory leads, including direct interaction with regulatory agencies, preferred
- Working with policies, procedures and SOPs
- Knowledge of legislation and regulations relating to medicinal products
- Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals.
- Knowledge of drug development
- Communication skills - both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to anticipate and prevent potential issues
- Knowledge of and experience in regional regulatory environment in relevant product area and development stage
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.