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    • Provide pharmaceutical, analytical, and other technical information to our affiliates, independent associated companies to assist with the registration and…
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    • Practical experience and/or experience in the pharmaceutical industry or manufacturing of biological/immunological product.
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    • Managing regulatory submissions and dossier preparation for medical devices or pharmaceuticals.
    • 3–7 years' experience in regulatory affairs, quality assurance…
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    • Managing regulatory submissions and dossier preparation for medical devices or pharmaceuticals.
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    • Experience within a regulated manufacturing environment, such as medical devices (ISO 13485), pharmaceuticals or similar.
    • On call rotation to cover weekends.

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Job Post Details

Sr. Regulatory Affairs Officer - job post

Milpharm Ltd
1 Roundwood Avenue, Uxbridge UB11 1AF
£30,000 - £38,000 a year - Full-time
Responded to 51-74% of applications in the past 30 days, typically within 12 days.

Job details

Pay

  • £30,000 - £38,000 a year

Job type

  • Full-time

Location

1 Roundwood Avenue, Uxbridge UB11 1AF

Benefits

Pulled from the full job description

  • Life insurance
  • Company pension
  • Company events
  • On-site parking

Full 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: £30,000.00-£38,000.00 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

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