p>Shreeya Patel at CK Clinical is recruiting a Regulatory Affairs Manager to join the generics division of a global pharmaceutical company at their site in Surrey on a permanent basis.
This is an exciting time to join the company as they have recently been recognised as the top performing company globally.
As Regulatory Affairs Manager you will be managing the Drug Regulatory Affairs (DRA) department to ensure:
- Fast and efficient preparation and submission of registration dossiers to obtain Regulatory Authority Approval for new products via co-ordination with European Regulatory Competence Centre.
- Maintenance of existing licenses, via co-ordination with European Regulatory Competence Centre, including marketing authorisations, manufacturing, import, wholesale dealer and Home Office licenses.
- Continued compliance with all relevant legislation, guidelines and practices, including EU, MHRA, Group and local requirements.
- Effective organisation of workload to achieve company objectives.
- Development of personnel to ensure they are suitably equipped and trained to perform their tasks effectively. Providing regulatory
advice to Sandoz personnel as required.
- Effective team working with Artwork, PV, Supply Chain, QA, Technical, Marketing, and other departments to achieve company objectives.
The successful candidate will have:
- BSc (Hons) chemistry or life sciences (upper second class or higher) required. MPharm (Pharmacy) highly desirable
- Experience within a senior RA role, within a Generic or Pharma business. Past experience managing a DRA team desirable
- Excellent knowledge of Centralised, Decentralised, National, Repeat Use and Mutual Recognition
- Procedures and application of Variation Categories.
- Proven track record of working with MHRA.
- Strong CMC background, experience in application of biowiavers highly desirable.
- Strong analytical approach balanced with a keen eye for detail demonstrated in all document control and administration undertaken. High degree of computer literacy in the use of both scientific and other role related software applications.
- Strong communication and leadership skills with the ability to select, motivate, train and develop staff to achieve both company and personal goals. Promotes an open style of communication.
- Proven track record in the delivery of regulatory, technical and scientific projects.
- Strategic and entrepreneurial thinker with the ability to provide a strong results focus for project teams to achieve goals and time sensitive deadlines to deliver what is needed to achieve the overall business results.
- Skilled user of Microsoft Word, Outlook and Excel, ideally experienced with SAP.
- Looks for synergies, facilitates cross DRA interactions.
- Experience in working within a pharmaceutical development or quality assurance department desirable.
- Experience with internal/external inspections desirable.
How to apply
For more information or to apply for this role, please contact Shreeya Patel on 01438 743047 or email firstname.lastname@example.org. Please quote reference CL25827 in all correspondence.
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