Regulatory Specialist
BBBH94542_1757330248
Posted: 08/09/2025
- Negotiable
- Hertfordshire
- Permanent
Regulatory Affairs Specialist (Pharma)
Circa £50k DOE
Full time ON-SITE. No Hybrid/Remote.
We are seeking an experienced Regulatory Affairs Specialist to join a growing pharmaceutical business and play a key role in ensuring compliance across development, manufacturing, and commercialisation activities. This role will focus on regulatory submissions, product registrations, and maintaining compliance with evolving MHRA, EMA, and ICH requirements.
You'll be responsible for preparing and submitting marketing authorisations, variations, and post-approval documentation, while also reviewing labelling and packaging to ensure regulatory accuracy. Acting as a key liaison with health authorities, you'll advise on regulatory strategy and support inspections, surveillance, and cross-functional compliance initiatives.
We're looking for someone with 5+ years of experience in pharmaceutical regulatory affairs, strong knowledge of global regulatory frameworks, and hands-on experience with eCTD and related document management tools. Excellent communication skills and the ability to work across teams are essential.
If you're keen to apply your expertise in a cooperative, fast-moving environment, this is a fantastic opportunity to make an impact on the successful delivery of pharmaceutical products to market.
Matthew Woods
Business Manager