MANAGER- REGULATORY AFFAIRS

Recruiter
Bristol Laboratories Ltd
Location
Luton, UK
Salary
Competitive
Posted
23 May 2019
Closes
27 May 2019
Ref
1142759060
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
MANAGER- REGULATORY AFFAIRS

£40,000 - £45,000 per annum

Location: Luton, Bedfordshire

Bristol Laboratories Ltd is one of the leading pharmaceutical companies in the United Kingdom engaged in the development, manufacturing, marketing and distribution of generic medicines, as well as formulation brands. We have state of the art manufacturing facility in Luton & Peterlee.

We are currently looking for a Manager - Regulatory Affairs in Luton.

Job description

Job Accountabilities will include:
  • Compilation, Review and Submissions of applications for EU and non EU markets.
  • Compilation, Review and Submission of Variations/Renewals/Sunset extensions of all granted Marketing Authorizations.
  • Compilation and Responding to Queries raised by various Agencies.
  • Reviewing and ensuring adequacy of CMC sections of dossiers/variations/responses for compliance to EU regulations.
  • Optimizing dossier submission and review timelines for new product and variation applications through continuous improvements to accomplish Right First Time Approvals.
  • Artwork Management System, PIQ submission and approval along with Readability testing and approval.
  • Activities related to Maintenance and Compliance of Bristol's products and licences to EU Pharmacovigilance legislations.
  • Participate in DSRMs and follow up with timely submission, approval & implementation of safety variations impacting the product information.
  • Delegate tasks and responsibilities to RA team members and ensuring timely completion of assigned activities.
  • Training the team on various Regulatory Topics.
  • Keeping abreast with the latest guidelines and regulations.
  • Review and Maintenance of Product License Files and Finished Product Specifications and Method of Analysis.
  • Any other function that may be required to fulfill regulatory commitments/filings or data base maintenance of regulatory affairs department
  • Liaising with various regulatory authorities in the EU member states.
  • Preparation and review of departmental Regulatory SOPs as required.

Knowledge & Skills Required:
  • Academic achievement to Post graduate Degree level in a Science based discipline.
  • Management experience in Regulatory Affairs in Pharmaceutical industry.
  • Firm understanding of Regulatory activities /cGMP/cGLP and QMS procedures in a pharmaceutical manufacturing unit as well as in warehousing and distribution.
  • Should have sound knowledge on computer validation

The last date for application of this job vacancy will be 31st May 2019

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