Director Global Regulatory Affairs

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.