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Regulatory Affairs Manager

Job Field:
Regulatory and Drug Safety Jobs
Discipline:
Regulatory Affairs Jobs
Country:
United Kingdom
Region:
East Sussex
Contract Type:
Permanent
Currency:
£
Salary:
50,000 to 54,000 per annum
Salary Description:
bonus and benefits
Posted:
14-Sep-18
Recruiter:
Key People
Job Ref:
1704-2

An excellent opportunity has arisen for a Regulatory Manager / Team Leader to join a global team within a specialist Pharmaceutical company based on the 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 with internal & 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 of 5+ 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 about this role or other opportunities within Regulatory Affairs please contact Tim Barratt on +44 (0) 1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk

Closing Date:
22/09/2018

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