Regulatory Affairs Consultant – 6+ months – Pharma – UK
AL Solutions are searching for an experienced Regulatory Affairs Consultant to work for a medium-sized international Pharmaceutical company HQ’d in Cambridge. This position has flexibility for home-based working.
Initial contract length 6 months, likely to extend.
This company have a headcount of approx. 1000 employees and have offices in the UK, Germany, and in the US.
The contractor is needed to assist with regulatory strategies and plans for development and approval of products across the designated territories, including Europe, Japan, China, Australia, US and Canada as required and for lifecycle management of products where applicable.
- Assist with the planning, coordination and preparation of MA applications for submission via National or European procedures
- Plan, prepare and submit variations to European MAs
- Coordinate and respond to questions from Regulatory Agencies during MA applications, MA renewals and variations
- Provide technical information to our Independent Associated Companies and Licensees, to assist with registration and maintenance activities of MAs in those countries
- Assist with the preparation of high quality briefing documents and meeting planning for Scientific Advice with Regulatory Agencies
- Manage the preparation, submission, approval and maintenance of multi-national clinical trial applications for development products, including co-ordination of responses to questions and variation management
- Be aware of and keep up to date with current legislation appropriate to Regulatory Affairs and provide expert advice on items or issues which will affect Regulatory and R&D project teams
- Participate in project teams and provide guidance in areas of expertise
- Participate in the review of department processes and assist or lead the development of procedures to enhance efficiency and effectiveness of the Regulatory Strategy group
- Provide guidance and support to other team members.
- Maintain records of tasks and registered product information in the internal regulatory databases and ensure submission documents are stored in the internal document management system
- Science degree or equivalent qualified: e.g. chemical and physical sciences, pharmacy, biochemistry, medical chemistry, biomedical science; or HND or equivalent industry experience where appropriate. A higher degree would be an advantage
- High level of technical regulatory experience, preferably obtained from a pharmaceutical company development environment, including experience with European marketing authorisation procedures for novel products, clinical trial applications and scientific advice procedures
- Excellent understanding of relevant Regulatory Guidelines and legislation, including Europe and preferably other international territories
- Excellent analytical and problem-solving skills
- Ability to influence internal and external bodies
- Possesses excellent written and oral communication skills
- Ability to work independently as well as actively working as a team member
- Positive work style, with an approachable, flexible manner
- Demonstrated project management ability
- Has a high attention to accuracy and detail
- Is IT literate particularly in relation to using databases and document management systems
AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.al2s3.com or reach out to us via: