Regulatory Affairs Manager, Sussex

Key People


Job ID :

9473


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,East Sussex,East Sussex,


Key Skills :

regulatory affairs, cta, clinical, development, post approval, registrations, manager, team leader,


Salary :

£50000 - £54000 per annum + bonus and benefits


Date Posted :

14 Nov, 2017



Company Name :

Key People


Location1 :

East Sussex




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

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


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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