Job Reference: 1704-2
Job Duration:
Start date: a.s.a.p
Description:
An excellent opportunity has arisen for a Regulatory Manager / Team Leader to join a global team within a specialist Pharmaceutical company based onthe south coast. Within this role you will gain a large amount of exposure working closely with R&D, QA and PV teams and lead a team of Regulatory professionals.
Job Specific Responsibilities:
- Line manage a team of regulatory officers and senior officer
- Ensure regulatory systems, such as Regulatory Database /trackers are implemented and kept up to date.
- Work withinternal & external customers to provide data and accurate regulatory input
- Prepare & review labelling/Packaging text. Promotional reviews *Communicate with regulatory agencies and document communication
- Prepare, Review and sign off change control risk assessments
- All paper and electronic files kept up to date and easily locatable
- Input into team activities e.g. brainstorming, best practices etc.
- Prepare & review assigned SOPs
- Prepare & review new product dossiers and annual updates
- Preparation & review of high quality timely submissions/responses and follow up of actions arising from Regulatory Authority commitments
- Review and approval of CTA/IND submission and maintenance documentation
- Prepare & review new product dossiers and annual updates
Qualifications/Experience required:
- Relevant life sciences degree
- Minimum of5+ years in the pharmaceutical field
- Ideally previous line management experience
- Demonstrated ability to write good quality documents
- Communication skills
- Attention to detail/accuracy
- Project management
- Breadth of technical regulatory knowledge & regulatory procedures in a variety of markets
- Proficient user of Microsoft Office
For further details aboutthis role or other opportunities within Regulatory Affairs please contact Tim Barratt on +44 (0) 1727 817 626 or email a copy ofyour CV to tbarratt@keypeople.co.uk
Industry: Pharmaceuticals
Salary: £50000 - £54000 per annum + bonus and benefits
Salary Benefits: bonus and benefits
Vacancy Type: Permanent
Job Skills: regulatory affairs, cta, clinical, development, post approval, registrations, manager, team leader, line manager
Contact Name: Tim Barratt
Website: -
Direct Application URL: -