Sr. Regulatory Affairs Officer

• 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.

• 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.

Pay: £35,000\.00\-£37,000\.00 per year

Benefits:

• Company events


• Company pension


• Life insurance


• On\-site parking

• Uxbridge UB11 1AF: reliably commute or plan to relocate before starting work (required)

• Regulatory Affairs (Pharma) for UK Market: 5 years (required)

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