Regulatory Affairs Manager, Sussex

Recruiter
Key People Limited
Location
East Sussex
Posted
12 Jan 2018
Closes
11 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
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 Phone number removed or email a copy of your CV to Email address removed