Sr. Regulatory Affairs Officer Job in Milpharm Ltd

Sr. Regulatory Affairs Officer

Ruislip, ENG, GB, United Kingdom

Apply Now

Job Description

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: 33,000.00-36,000.00 per year

Benefits:

Company events Company pension Life insurance On-site parking
Ability to commute/relocate:

Ruislip HA4 6QD: reliably commute or plan to relocate before starting work (required)
Experience:

Regulatory Affairs (Pharma) for UK Market: 5 years (required)
Work Location: In person

Beware of fraud agents! do not pay money to get a job

MNCJobs.co.uk will not be responsible for any payment made to a third-party. All Terms of Use are applicable.