Regulatory Affairs Manager
- Experience Level
- Full-time permanent position
- Office based in Essex
- Competitive package
- The Regulatory Manager/Senior Manager provides development stage advice to internal staff and to clients for a broad range of programmes.
- Provide EU regulatory affairs advice to clients developing a wide variety of medicinal products. Lead EMA procedures including orphan applications, PIPs and Scientific Advice.
- Provide expert EU regulatory strategy. Regulatory lead and point of contact for national agency and EMA interactions.
- Advise global clinical development teams in the requirements for EU based programmes, and to integrate with other regional experts.
Full job description available on application
- 3+ years European regulatory affairs experience with demonstrable experience in liaising and negotiating with regulatory authorities.
- Demonstrable experience in scientific advice meetings, CTA, orphan applications and/or PIPs.
- Strong understanding of the regulatory environment including guidelines.
- Ability to work under pressure and achieve timely submission and regulatory approvals.
- Client are considering candidates from Associate Reg Affairs Manager through to Senior Reg Affairs Manager level.
- Only candidates with existing right to work in the UK/EU will be considered
Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email email@example.com
To view our other vacancies, please visit our website on www.apexrecruitment.com
Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.
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