Regulatory Strategic Lead
Offering up to £100,000 Per Annum, Car Allowance and attractive benefit package
Office based Oxford
CPL Life Sciences is collaborating with a global leader is developing innovative products in medical devices and diagnostics. This organization has been instrumental in the research and development of a number of leading products in the market with an exceptionally strong pipeline of products in development.
An opportunity has arisen within the Regulatory team for a Regulatory Strategic Lead. Within this position you will be combining your regulatory strategic background to ensure and enable products are developed, manufactured or distributed to meet required legislation.
Job responsibilities include;
- Evaluate regulatory risks of corporate policies and translate that understanding into strategic guidance for product development and planning throughout the product lifecycle
- Develop global regulatory strategies
- Identify new regulatory policies, processes and SOP’s
- Utilize technical regulatory skills to propose strategies on complex issues.
- Lead crisis management program development and implementation
- Provide strategic input and technical guidance on regulatory authority queries.
- Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
- Negotiate internally and externally with regulatory agencies and participate in political lobbying.
- Approve regulatory filing strategies based upon proposed preclinical, clinical and manufacturing charges
Candidate Requirements include;
- Eligible to live and work in the United Kingdom
- Life Sciences degree at Bachelors or Masters level
- Must be able to commute to offices in Oxfordshire
- In-depth background working in Regulatory Affairs on Medical Device/Diagnostic products
- Previous regulatory strategy experience
If this position is of interest to yourself please forward your up to date CV to sophie.malyon@cpl.com.
