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- Tasks: Lead regulatory strategy and submissions for innovative biologic products.
- Company: Join a cutting-edge pharma company focused on expanded access and biologics.
- Benefits: Enjoy hybrid working, competitive salary, and opportunities for professional growth.
- Why this job: Be at the forefront of regulatory affairs in a dynamic and impactful environment.
- Qualifications: Degree in life sciences and 10+ years in pharmaceutical regulatory roles required.
- Other info: Must have right to work in the UK and commute weekly to the office.
The predicted salary is between 72000 - 108000 £ per year.
Blackfield associates are continuing our support for an innovative expanded access pharma company with a new Biologics project. We’re looking for an experienced Regulatory Director to join their Greater London based UK office.
Responsibilities:
- Regulatory Leadership & Strategy: Lead all aspects of Biologic Product Regulatory activities as a subject matter expert. Establish regulatory priorities and coordinate with Regulatory Affairs consultants, Quality, Manufacturing, Science & Technical (MSAT), Pharmacovigilance, and Medical Affairs teams to drive effective submission, approval, and implementation processes for the product range. Ensure regulatory strategy aligns with business goals for biologics.
- Regulatory Submissions & Compliance: Oversee and execute high-quality regulatory submissions, ensuring alignment with internal stakeholders. Drive positive interactions with Regulatory Authorities (e.g. MHRA, EMA, US FDA) to facilitate smooth submission processes. Action, review, and advise on marketing authorisation holder (MAH) communication with competent authorities on regulatory and product-specific matters, including applications, scientific advice, product defects, and recalls.
- Product Development & Change Controls: Lead regulatory activities for new biologic product acquisitions, advising on Marketing Authorisation (MA) transfers or developing regulatory strategies for new product submissions. Lead the review of change controls from both internal and external sources related to marketing authorisations and MAH responsibilities.
- Clinical & Pharmacovigilance Support: Operate both internally and externally to fulfill strategic regulatory and business goals. Accountable for regulatory delivery through others, ensuring regulatory strategy aligns with overall business objectives.
Qualifications:
- Educated to Degree level in related Life science disciplines.
- Extensive, hands-on experience with EU regulatory requirements, ideally strong knowledge or familiar with US requirements.
- Must have proven background in Biologics, either developing strategy and implementation or taking projects from development to successful registration.
- Previous experience in a higher-level role such as Associate Director or Senior Lead, with direct line management experience.
- Held/chaired Scientific advice meetings.
- Minimum 10 years’ experience, gained in pharmaceutical drug development.
This is a hybrid working role, with no ability to sponsor. Applicants must hold valid right to work in the UK and be able to commute weekly to our client's office.
Director of Regulatory Affairs employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director of Regulatory Affairs
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with biologics. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the sector.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements of the MHRA, EMA, and US FDA. Understanding their processes and expectations will not only enhance your knowledge but also demonstrate your commitment to the role during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences in leading regulatory submissions and interactions with regulatory authorities. Be ready to provide examples of how you successfully navigated challenges in past projects, particularly in biologics.
✨Tip Number 4
Showcase your leadership skills by highlighting any direct line management experience you have. Discuss how you've effectively coordinated teams across different departments to achieve regulatory goals, as this is crucial for the Director role.
We think you need these skills to ace Director of Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your extensive experience in regulatory affairs, particularly in biologics. Emphasise any leadership roles you've held and specific projects that align with the responsibilities outlined in the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your understanding of the regulatory landscape for biologics. Discuss your strategic approach to regulatory submissions and how your experience aligns with the company's goals.
Highlight Relevant Experience: In your application, focus on your hands-on experience with EU and US regulatory requirements. Provide examples of successful regulatory submissions and interactions with authorities like the MHRA and EMA.
Showcase Leadership Skills: Since the role requires direct line management experience, be sure to mention any teams you have led or mentored. Highlight your ability to coordinate with various departments to achieve regulatory success.
How to prepare for a job interview at Blackfield Associates
✨Showcase Your Regulatory Expertise
As a candidate for the Director of Regulatory Affairs, it's crucial to demonstrate your deep understanding of regulatory frameworks, especially in relation to biologics. Be prepared to discuss specific examples from your past experiences where you successfully navigated complex regulatory challenges.
✨Align with Business Goals
Make sure to articulate how your regulatory strategies have previously aligned with broader business objectives. This will show that you not only understand the regulatory landscape but also how it fits into the company's success.
✨Prepare for Authority Interactions
Expect questions about your experience with regulatory authorities like the MHRA and EMA. Prepare to share instances where you facilitated positive interactions or resolved issues during submission processes, as this is key for the role.
✨Demonstrate Leadership Skills
Since this role involves leading teams and managing projects, be ready to discuss your leadership style and provide examples of how you've effectively managed cross-functional teams in previous roles. Highlight any direct line management experience you have.
