Director Global Regulatory Affairs

Blackfield Associates; Greater London; Remote; GBP 80,000 - 120,000

Job description

Direct message the job poster from Blackfield Associates

Senior International Consultant - Regulatory Affairs and Executive Search

Blackfield Associates are proud to be exclusively partnered with a specialty 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:

1. Develop, manage, and implement comprehensive regulatory strategies to approval pathways and lifecycle management for product pipeline, including global registrations and licensing.
2. Act as the regulatory point of contact and subject matter expert for all initial and lifecycle management submissions of marketing applications and historical clinical applications.
3. Liaise between Quality and Clinical departments, as well as wider company stakeholders, and communicate impacts and risk factors of changing regulations to the business.
4. Function as the primary liaison with health authorities including FDA, EMA, MHRA, leading interactions, negotiations, and advisory meetings as well as commercial opportunities.
5. Drive further approval in emerging or new markets such as APAC.
6. Ensure compliance with GxP regulations, including GMP, GCP, pharmacovigilance, and promotional requirements cross-functionally.
7. Lead regulatory due diligence for in-licensing and business development opportunities.

To be considered for the role of Regulatory Affairs Director, you will:

1. Have a proven minimum of 10 years of regulatory affairs experience in pharmaceuticals/biotech, with at least 3 years in a leadership role with direct reports.
2. Hold an advanced degree in life sciences including Pharmacy, Chemistry, Biochemistry; postgraduate qualification preferred.
3. Have previous new submissions experience with APAC regions including China, Korea, and Asia.
4. Possess expertise in regulatory pathways within haematology, endocrinology, women’s health, gastroenterology; nephrology would be advantageous.
5. Have effectively participated in face-to-face interactions with relevant regulatory authorities, particularly FDA, at key stages of development. Must have led scientific advice meetings and IND meetings. Ideal experience of end-Phase II/III meetings and advisory committees will be desirable.
6. Have previous experience of cross-functional leadership or oversight of Clinical Development or Quality Assurance teams.
7. Be a hands-on, proactive motivator, looking to take charge and grow 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.

Seniority level

Director

Employment type

Full-time

Job function

Pharmaceutical Manufacturing, Biotechnology Research, and Construction