I’m working with an innovative, growing biotech who are looking to bring in a Senior Manager, Regulatory Affairs to support their clinical-stage pipeline.
This is a hands-on role in a lean environment, ideal for someone who enjoys working close to the science and taking ownership across both strategy and execution. You’ll be supporting global regulatory activities across early to mid-stage development programs, working cross-functionally with CMC, clinical, and non-clinical teams.
What you’ll be doing:
- Supporting and contributing to global regulatory strategy
- Preparing and managing regulatory submissions (INDs, CTAs, amendments)
- Working closely with internal teams and external partners to ensure alignment across development activities
- Supporting interactions with health authorities across the US, UK, and EU
- Providing regulatory input into study design, protocols, and development plans
- Tracking regulatory requirements and supporting compliance activities
What they’re looking for:
- Experience in Regulatory Affairs within biotech/pharma
- Strong exposure to clinical trial applications and regulatory submissions
- Understanding across CMC, clinical, and non-clinical components
- Ability to work independently and manage multiple priorities
- Comfortable in a fast-paced, evolving environment
Experience in advanced therapies, biologics, or complex products would be beneficial, but not essential.
This is a great opportunity to join a small, high-impact team where you’ll have real visibility and ownership.
”, “datePosted”: “2026-05-01”, “hiringOrganization”: { “@type”: “Organization”, “name”: “Advanced Clinical”, “sameAs”: “https://uk.whatjobs.com/pub_api__cpl__419497230__4861?utm_campaign=publisher&utm_medium=api&utm_source=4861” }, “jobLocation”: { “@type”: “Place”, “address”: { “@type”: “PostalAddress”, “addressLocality”: “” } } }I’m working with an innovative, growing biotech who are looking to bring in a Senior Manager, Regulatory Affairs to support their clinical-stage pipeline.
This is a hands-on role in a lean environment, ideal for someone who enjoys working close to the science and taking ownership across both strategy and execution. You’ll be supporting global regulatory activities across early to mid-stage development programs, working cross-functionally with CMC, clinical, and non-clinical teams.
What you’ll be doing:
- Supporting and contributing to global regulatory strategy
- Preparing and managing regulatory submissions (INDs, CTAs, amendments)
- Working closely with internal teams and external partners to ensure alignment across development activities
- Supporting interactions with health authorities across the US, UK, and EU
- Providing regulatory input into study design, protocols, and development plans
- Tracking regulatory requirements and supporting compliance activities
What they’re looking for:
- Experience in Regulatory Affairs within biotech/pharma
- Strong exposure to clinical trial applications and regulatory submissions
- Understanding across CMC, clinical, and non-clinical components
- Ability to work independently and manage multiple priorities
- Comfortable in a fast-paced, evolving environment
Experience in advanced therapies, biologics, or complex products would be beneficial, but not essential.
This is a great opportunity to join a small, high-impact team where you’ll have real visibility and ownership.
…