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Regulatory Affairs Specialist

2 months ago

Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full time

About Select Pharma Limited

Select Pharma Limited is a leading pharmaceutical company that specializes in the development and manufacturing of generic solid dosage products. We are seeking a highly skilled Regulatory Affairs Specialist to join our team and contribute to the success of our business.

Job Summary

We are looking for a Regulatory Affairs Specialist to support our Regulatory Affairs team in ensuring compliance with regulatory requirements and guidelines. The successful candidate will be responsible for preparing and submitting high-quality regulatory applications, maintaining marketing authorizations, and interfacing with regulatory authorities.

Key Responsibilities

  1. Regulatory Application Preparation

Prepare and submit reliable quality regulatory applications to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in a timely manner.

Regulatory Compliance

Have a good understanding of and be able to execute activities related to key areas such as:

  • Variations: Type 1A, 1B, II, Labelling changes including own label supplies, safety updates, and line extensions.
  • Reclassification of Medicines.
  • Re-baseline / Remediation dossiers.
  • License Transfers (giving away and bringing in) including the due diligence of dossiers.
  • Maintenance of Marketing Authorisations including renewals.
  • Deficiency responses to authorities.
Regulatory Interface

Partake in the interfacing with regulatory authorities to facilitate the approval of submissions.

Team Collaboration

Act as a point of contact for other business units, customers, and internal/external teams.

Regulatory Knowledge

Stay informed about new and changing regulatory requirements and ensuring compliance.

Training and Development

Assist in coaching and mentoring junior members of the team.

Regulatory Advice

Liaise with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business.

Requirements

  1. Education

Pharmacy/Chemistry degree.

Experience

A background in R&D and manufacturing industries.

Regulatory Affairs Experience

Significant Regulatory Affairs experience.

Regulatory Knowledge

Understanding of the current UK and European regulations, laws, guidelines, and industry requirements.

Technical Skills

Exposure to NeeS/eCTD format and electronic submission gateways is preferable.

Additional Skills

Experience with Generic products and MRP/DCP submissions is advantageous.

Working Arrangements

  • Full-time position.
  • Monday to Friday.
  • On-site work location.

Compensation and Benefits

  • Salary: £35,000.00-£38,000.00 per year.
  • Bonus scheme.
  • Company pension.
  • Free parking.