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- Tasks: Lead and implement innovative regulatory strategies globally while ensuring compliance.
- Company: Join a rapidly growing healthcare company focused on impactful regulatory affairs.
- Benefits: Enjoy a hybrid work model with flexibility and opportunities for professional growth.
- Why this job: Be a key player in shaping regulatory strategies that drive business success and innovation.
- Qualifications: Masters in a relevant scientific field and extensive experience in global regulatory affairs required.
- Other info: Candidates must be within a reasonable commute for a hybrid office presence.
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.
As Regulatory Affairs Director, you will have the following 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.
To be considered for the role of Regulatory Director, you will have:
- Educated to Degree level in related Life science disciplines
- Extensive, hands-on experience with EU regulatory requires, ideally strong Knowle 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 higher level role such as Associate Director or Senior Lead- with direct line management experience
- Held/ chaired Scientific advise 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 able to commute weekly to our clients 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
Make sure to stay updated on the latest global regulatory changes, especially those related to the pharmaceutical and biotech industries. This knowledge will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, particularly those who have experience with MHRA, EMA, and FDA. Engaging in discussions or attending industry events can provide valuable insights and connections that may benefit your application.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully led regulatory strategies in previous roles. Highlighting your hands-on experience and leadership skills will be crucial in showcasing your fit for this senior position.
✨Tip Number 4
Familiarize yourself with the company's current regulatory challenges and objectives. Tailoring your approach to show how you can address these issues will set you apart as a strategic partner who understands their business needs.
We think you need these skills to ace Director of Regulatory Affairs
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Regulatory Director position. Highlight key responsibilities and required qualifications that align with your experience.
Tailor Your CV: Customize your CV to emphasize your extensive experience in global regulatory affairs, leadership roles, and specific achievements related to regulatory submissions and interactions with health authorities like the MHRA, FDA, and EMA.
Craft a Compelling Cover Letter: Write a cover letter that showcases your entrepreneurial approach and ability to develop innovative regulatory strategies. Mention specific examples of how you've successfully led teams and managed regulatory documents.
Highlight Relevant Experience: In your application, focus on your hands-on experience with preparing and maintaining dossiers for clinical trials and marketing authorizations. Discuss your deep GxP knowledge and any direct experience with regulatory authorities.
How to prepare for a job interview at Blackfield Associates
✨Showcase Your Regulatory Expertise
Be prepared to discuss your extensive experience in global regulatory affairs. Highlight specific examples of how you've successfully navigated complex regulatory environments and achieved timely approvals from health authorities like the MHRA, FDA, and EMA.
✨Demonstrate Leadership Skills
Since this role requires leadership experience, be ready to share your approach to leading teams. Discuss how you've built a culture of trust and communication, and provide examples of how you've developed your team's skills and capabilities.
✨Align with Business Objectives
Emphasize your ability to act as a strategic partner to the business. Prepare to discuss how you've previously aligned regulatory strategies with company objectives and contributed to due diligence activities.
✨Stay Updated on Global Regulations
Show that you maintain contemporary knowledge of global regulations. Be ready to discuss recent changes in the regulatory landscape and how they might impact the company's strategy, demonstrating your proactive approach to risk identification and mitigation.
