- Participate in project teams and provide guidance in areas of expertise for both research and marketed products.
- Follow up on technical-regulatory and scientific issues
- Managing projects within regulatory department
- Ensure appropriate standards and policies are maintained for all technical aspects of the company’s regulatory activities
- Co-ordinate and prepare MA, variation applications for submission via National or European procedures.
- Provide pharmaceutical, analytical, and other technical information to our affiliates, independent associated companies to assist with the registration and maintenance activities of existing MAs.
- With appropriate support, plan responses to questions from Regulatory agencies during MA applications, MA renewals and variations.
- Provide responses to regulatory questions relating to our group companies products registered or undergoing registration.
- Assist with the maintenance of all MA’s with appropriate support.
- Learn and be aware the current legislation, guidelines, and other relevant technical and scientific information appropriate for the role.
- Maintain records of tasks and registered product information in the internal regulatory databases.
- Take personal responsibility for representing the Department both internally and externally in own area of expertise.
- Take responsibility for decision making within area of influence.
Must Have:
- At least 5 years’ experience in Regulatory Affairs is preferable.
- Preferable master's degree or equivalent qualification in Pharmaceutical sciences, Pharmaceutical analysis or Pharmaceutical formulation.
- IT literate particularly in relation to using databases and document management system.
Job Type: Full-time
Pay: £30,000.00-£37,500.00 per year
Benefits:
- Company events
- Company pension
- Life insurance
- On-site parking
Ability to commute/relocate:
- Uxbridge UB11 1AF: reliably commute or plan to relocate before starting work (required)
Experience:
- Regulatory Affairs (Pharma) for UK Market: 5 years (required)
Work Location: In person
