Pharma Regulatory Affairs Advisor
Pharma Regulatory Affairs Specialist Advisor, Ashton under Lyne, Greater Manchester
The Company is a leading pharmaceutical contract development and manufacturing organisation based in Ashton Under Lyne. They now have an opportunity for a Regulatory Affairs Specialist to work within the QA Department.
The successful candidate will be expected to provide regulatory advice and support to the company in order to obtain & maintain marketing authorisations for products owned by the company and to provide regulatory support for products manufactured behalf of external customers.
To assist Regulatory Affairs and Administration Manager in the maintenance of the company site licences.
- Receipt, logging and tracking of licence submissions, approvals, refusal notifications from clients
- Deputise for the Regulatory & Administration Manager (i annual leave/sickness)
- Provide regulatory assessment of Change Management Requests under the direction of the Regulatory Affairs and Administration Manager
- Review and approve batch production documentation (BMR/BPR/PA) and Quality Control procedures/records (QCTP/QCR) from a regulatory compliance and correspondence to client Marketing Authorisations perspective
- Ensure timely regulatory reviews and submissions to support ongoing manufacturing and new product introductions
- Support Technology Transfer activities, including writing of dossiers and assisting with timely submissions to competent authorities
- Liaise with clients in order to obtain Annual Product Quality Reviews, Stability Data and Technical Agreements in support of Qualified Person (QP) product release on site
- Assist in the management of regulatory inspections and client audits of the site
- To liaise directly with client companies and regulatory bodies concerning regulatory/QA issues
Skills / Experience:
- The successful candidate must be educated to degree level or equivalent BSc in Life Sciences, Pharmaceutical Sciences or equivalent.
- Have a Minimum of 24 months experience in regulatory affairs, plus additional experience in the industry.
- A strong regulatory background with knowledge of regulatory processes and legislative procedures with experience in UK/IE submissions is essential. Experience in European procedures - MRP, DCP, CP is desirable
Salary: £Competitive + Benefits
To Apply: Please press the 'Apply' button
*Due to the amount of applications received, only those who our client wishes to progress will be contacted. If you have not received correspondence within 21 days then please assume your application has been unsuccessful on this occasion. Thank you for reading this advertisement.
This role may be of interest to people interested in the following: Technical, Quality, Preventative, Pharmaceutical, Chemical, FMCG, Compliance, Food, Quality Assurance, Control, Quality Systems, Technologist, Manufacturing, Production, Microbiologist, QA, QC, Laboratory, Technician, Scientist, Science, Manchester, Lancashire, Cheshire