At a Glance
- Tasks: Lead and expand EU regulatory capability in a global CDMO environment.
- Company: Join a dynamic global CDMO focused on biologics and large molecules.
- Benefits: Remote work, competitive salary, and opportunities for professional growth.
- Other info: Travel opportunities and a chance to influence strategic regulatory functions.
- Why this job: Shape the future of biologics while collaborating with top industry professionals.
- Qualifications: 15+ years in Regulatory Affairs with a focus on biologics and large molecules.
The predicted salary is between 80000 - 100000 € per year.
Blackfield Associates are exclusively supporting the opportunity for a Regulatory Affairs Director to lead and expand EU regulatory capability within a global CDMO environment, with a strong focus on large molecule drug substances and Biologic products. This role sits at the intersection of client delivery, regulatory compliance, and commercial growth, acting as a key partner to both internal teams and external clients. You will play a central role in strengthening regulatory operations, enhancing service offerings, and supporting the successful development and manufacture of biologics across international markets.
Key Responsibilities:
- Provide matrix leadership across multiple EU & APAC manufacturing sites (large molecule focus)
- Partner with site leadership to build and develop regulatory capability aligned to client delivery needs
- Support hiring, onboarding, and mentoring of regulatory teams within a multi-site CDMO environment
- Act as a senior regulatory contact for CDMO clients, supporting development and commercial programmes
- Provide strategic regulatory guidance across drug substance (CMC) development, manufacturing, and lifecycle activities
- Support key client programs including tech transfers, scale-up, and global expansion initiatives
- Ensure high-quality, on-time regulatory deliverables aligned with client expectations
- Support commercial activities including regulatory input into proposals, quotations, and new business opportunities
- Oversee site compliance including licenses, SMF/DMF, regulatory documentation, and audit readiness
- Support quality event resolution and regulatory risk mitigation in collaboration with QA and site leadership
- Monitor and interpret changes in global regulatory requirements (EMA, FDA, ICH) with relevance to biologics manufacturing
- Provide internal SME support on regulatory strategy for CDMO clients and products
- Drive knowledge-sharing and capability building across the regulatory network
Experience & Qualifications:
- Advanced degree in Life Sciences (Pharmacy, Biology, Chemistry, etc.)
- 15+ years’ Regulatory Affairs experience, with a strong focus on biologics / large molecule CMC
- Proven experience in a CDMO or external partnering environment (Essential)
- Strong understanding of drug substance development, manufacturing, and regulatory submission requirements
- Deep expertise in EU regulatory frameworks, with exposure to APAC and global markets
- Demonstrated experience working with clients and managing external stakeholder relationships
- Proven leadership experience in matrix and multi-site environments
Additional Information:
- Travel required (~30%, primarily within Europe)
- Exposure to global CDMO operations and high-impact client programmes
- Opportunity to shape and grow a strategic regulatory function within a commercial environment
- Excellent stakeholder management across clients, regulators, and internal teams
- Ability to operate in a fast-paced, client-driven CDMO environment
- Strong communication, negotiation, and influencing skills
- Fluent English (additional languages advantageous)
This is a full time, permanent role. Remote based in the UK. Due to the matrix requirements of the role, applicants from a predominately perm background only being considered- not suitable for contractor/ consultants.
Director of Regulatory Affairs EU in London employer: Blackfield Associates
At Blackfield Associates, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the field of regulatory affairs. Our remote-based role for the Director of Regulatory Affairs EU provides unparalleled opportunities for professional growth, with access to global CDMO operations and high-impact client programmes, all while supporting the development of biologics across international markets. Join us to be part of a team that values strategic leadership and empowers you to make a significant impact in a fast-paced environment.
StudySmarter Expert Advice🤫
We think this is how you could land Director of Regulatory Affairs EU in London
✨Network Like a Pro
Get out there and connect with people in the industry! Attend conferences, webinars, or local meetups related to regulatory affairs. The more you engage with others, the better your chances of hearing about job openings that might not even be advertised.
✨Showcase Your Expertise
When you get the chance to chat with potential employers, don’t hold back on sharing your knowledge. Discuss recent changes in EU regulations or share insights on biologics manufacturing. This will position you as a thought leader and make you memorable!
✨Leverage LinkedIn
Make sure your LinkedIn profile is up-to-date and reflects your extensive experience in regulatory affairs. Join relevant groups and participate in discussions. You never know who might reach out with an opportunity that’s perfect for you!
✨Apply Through Our Website
Don’t forget to check out our website for the latest job openings! Applying directly through us can give you an edge, as we’re always looking for passionate individuals who want to make a difference in the regulatory landscape.
We think you need these skills to ace Director of Regulatory Affairs EU in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Director of Regulatory Affairs EU. Highlight your experience in regulatory affairs, especially with biologics and large molecules, and showcase any leadership roles you've held in a CDMO environment.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for this position. Use specific examples from your past experiences that align with the key responsibilities mentioned in the job description, and don't forget to express your enthusiasm for the role!
Showcase Your Leadership Skills:Since this role involves matrix leadership across multiple sites, make sure to highlight your leadership experience. Share examples of how you've successfully led teams and managed stakeholder relationships in a fast-paced environment.
Apply Through Our Website:We encourage you to apply directly through our website. This ensures your application gets to the right people quickly and allows us to keep track of all applicants efficiently. Plus, it’s super easy!
How to prepare for a job interview at Blackfield Associates
✨Know Your Regulatory Stuff
Make sure you brush up on the latest EU regulatory frameworks, especially around biologics and large molecules. Being able to discuss recent changes or trends in regulations will show that you're not just knowledgeable but also proactive in your field.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams in a matrix environment. Highlight specific instances where your leadership made a difference in regulatory compliance or client delivery, as this role requires strong leadership across multiple sites.
✨Understand the CDMO Landscape
Familiarise yourself with the dynamics of working in a Contract Development and Manufacturing Organisation (CDMO). Be ready to discuss how you can enhance service offerings and support commercial growth, as this is key to the role.
✨Engage with Stakeholders
Think about how you've managed relationships with clients and regulators in the past. Prepare to share strategies for effective communication and negotiation, as building strong partnerships is crucial for success in this position.
