Snr Reg Officer/ Regulatory Affairs Manager - Herts

Recruiter
Capital Pharma
Location
Hertfordshire
Posted
11 Jan 2018
Closes
17 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Regulatory Affairs Manager

Description

Manage a team of registration officers within the UK affiliate

- o Setting goals
- o Coaching and developing staff
- o Conduct performance appraisals

- Oversee and prepare the compilation of high standard regulatory submissions (for generic and branded

products) in line with company requirements and timelines.

- Good all round regulatory knowledge (CMC, labelling, artwork)
- Ensure regulatory compliance of UK and Malta products with relevant national and European regulatory

requirements

- Maintain a good knowledge of current UK guidelines and other regulatory issues to ensure information is

used to change and optimize procedures and communicate to appropriate stakeholders

Here are the minimum qualifications and essential functions for this position:

- Minimum BSc in Life sciences or related area.
- High degree of technical competence in regulatory affairs (both branded and generic experience desirable)
- Affiliate experience desirable/or a strong wish to move into this area
- People management experience essential
- Excellent communication skills
- Highly developed project management skills
- Self-starter and highly motivated