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- Tasks: Lead regulatory strategies and manage product approvals in a dynamic pharmaceutical environment.
- Company: Join a growing specialty pharmaceutical client making waves in the industry.
- Benefits: Enjoy remote work flexibility with occasional travel for team meetings.
- Why this job: Be at the forefront of regulatory affairs, impacting global health and driving innovation.
- Qualifications: 10+ years in regulatory affairs, with leadership experience and advanced life sciences degree required.
- Other info: Must have valid Right to Work in the UK; no sponsorship available.
The predicted salary is between 72000 - 108000 £ per year.
Blackfield Associates are proud to be exclusively partnered with a speciality pharmaceutical client, who due to growth, are looking to hire a Regulatory Affairs Director to join their UK based team; to be the overall lead for the Regulatory function.
As Regulatory Affairs Director, you will:
- Develop, manage, and implement comprehensive regulatory strategies to approval pathways and lifecycle management for product pipeline, including global registrations and licensing
- Regulatory point of contact and subject matter expert for all initial and life cycle management submissions of marketing applications and historical clinical applications
- Liaise between Quality and Clinical departments, as well as wider company stakeholders and communicate impacts and risk factors or changing regulations to the business
- Function as the primary liaison with health authorities including FDA, EMA, MHRA, leading interactions, negotiations, and advisory meetings as well as commercial opportunities
- Drive further approval in emerging or new markets such as APAC
- Ensure compliance with GxP regulations, including GMP, GCP, pharmacovigilance, and promotional requirements cross functionally
- Lead regulatory due diligence for in-licensing and business development opportunities.
To be considered for the role of Regulatory Affairs Director, you will:
- Proven minimum 10 years of regulatory affairs experience in pharmaceuticals/biotech, with at least 3 years in a leadership role with direct reports
- Advanced degree in life sciences including Pharmacy, Chemistry, Biochemistry; postgraduate qualification preferred.
- Previous new submissions experience with APAC regions including China, Korea, Asia.
- Expertise in regulatory pathways within haematology, endocrinology, women’s health, gastroenterology. Nephrology would be advantageous
- Effectively participated in face-to-face interactions with relevant regulatory authorities, particularly FDA, at key stages of development. Must have led scientific advice meetings, IND meetings. Ideal experience of end-Phase II/III meetings, advisory committees will be desirable.
- Previous experience of cross functional leadership or oversight of Clinical Development or Quality Assurance teams
- Looking for a hands-on, proactive motivator, looking to take charge and growth with the company.
This is a permanent position, Remote working with an expectation of occasional travel depending on business needs or group meetings.
Unable to sponsor, must hold valid Right to Work in the UK, unrestricted.
Director Global Regulatory Affairs employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director Global Regulatory Affairs
✨Tip Number 1
Make sure to highlight your extensive experience in regulatory affairs, especially your leadership roles. Use specific examples of how you've successfully managed regulatory strategies and submissions, particularly in the pharmaceutical or biotech sectors.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with FDA, EMA, and APAC regions. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in regulatory affairs.
✨Tip Number 3
Demonstrate your ability to liaise effectively between different departments, such as Quality and Clinical teams. Share instances where you facilitated communication and collaboration to achieve regulatory compliance and successful product approvals.
✨Tip Number 4
Stay updated on the latest regulations and guidelines in the pharmaceutical industry, particularly those affecting haematology, endocrinology, and other relevant areas. This knowledge will not only help you in interviews but also show your commitment to staying at the forefront of regulatory affairs.
We think you need these skills to ace Director Global Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your extensive experience in regulatory affairs, especially your leadership roles and specific expertise in the pharmaceutical/biotech sectors. Emphasize your familiarity with global registrations and your interactions with health authorities like the FDA and EMA.
Craft a Compelling Cover Letter: In your cover letter, express your passion for regulatory affairs and how your background aligns with the company's needs. Mention your hands-on approach and ability to lead cross-functional teams, as well as your experience with emerging markets like APAC.
Showcase Relevant Achievements: Include specific examples of successful regulatory strategies you have developed or implemented. Highlight any significant approvals or submissions you led, particularly in haematology, endocrinology, or other relevant fields.
Prepare for Interviews: Be ready to discuss your previous experiences in detail, especially your interactions with regulatory authorities and your leadership style. Prepare to answer questions about how you manage compliance with GxP regulations and your approach to risk management.
How to prepare for a job interview at Blackfield Associates
✨Showcase Your Regulatory Expertise
Be prepared to discuss your extensive experience in regulatory affairs, especially your work with FDA, EMA, and other health authorities. Highlight specific examples of successful submissions and interactions that demonstrate your expertise.
✨Demonstrate Leadership Skills
Since this role requires leadership, share experiences where you led teams or projects. Discuss how you motivated your team and managed cross-functional collaborations, particularly in clinical development or quality assurance.
✨Understand the Company’s Product Pipeline
Research the company’s product pipeline and be ready to discuss how your regulatory strategies can align with their goals. Show that you understand the complexities of lifecycle management and global registrations.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills in regulatory challenges. Think about potential risks and impacts of changing regulations and how you would communicate these to stakeholders.
