Blackfield Associates have been exclusively retained to support the search for a strategic and commercial Vice President of Regulatory Affairs on behalf of a specialty pharmaceutical company, focused on their next phase of growth within their novel modality.
This is a rare opportunity to the leadership team, reporting directly to the CEO, and shape the global regulatory, quality, and pharmacovigilance strategy for a growing portfolio market and lead the expansion / acquisition of new pipeline products.
Key Responsibilities
* Define and lead global regulatory strategies to achieve product approvals and maintain registrations across international markets.
* Oversee the Quality Management System to ensure compliance with GxP standards and regulatory expectations.
* Lead regulatory submissions including FDA submissions and emerging market fillings such as marketing authorisations, variations, and renewals, act as single point of contact with the relevant health authorities
* Monitor and communicate regulatory changes, emerging trends, and strategic implications to the executive team and board.
* Ensure regulatory compliance across all product lifecycle stages, including support for partner-led clinical, registration, and post-marketing activities.
* Provide executive oversight of the global Pharmacovigilance function, ensuring operational excellence, regulatory compliance, and alignment with safety reporting standards.
* Collaborate with the Head of Pharmacovigilance to maintain and evolve PV systems and processes in line with global requirements.
* Guide clinical development strategy in collaboration with internal medical affairs and external consultants, ensuring alignment with ICH-GxP standards.
* Represent the company in scientific and regulatory forums, including advisory boards, investigator meetings, and investor presentations.
* Maintain oversight of clinical documentation and Trial Master Files (TMFs) in accordance with GCP.
* Lead and develop high-performing teams across Quality, Regulatory Affairs, and Pharmacovigilance functions.
Candidate experience and qualifications required to be considered:
* Advanced education/degree in life sciences, pharmacy, or medicine (PhD, MD, PharmD preferred)
* Extensive hands-on experience in regulatory affairs, quality, and pharmacovigilance within the pharmaceutical industry.
* Proven leadership in FDA interactions and global regulatory submissions- ideally Novel or leading to successful approval with partner companies
* A hands-on team player – someone comfortable to lead strategy implementation as well as personally handle variations and RTQ’s to health authorities
* Experience in therapeutic areas such as hematology, women’s health, GI, or CKD.
* Exceptional communication, project management, and stakeholder engagement skills.
* A hands-on, resilient leader with a strategic mindset and collaborative approach- candidates must be comfortable operating in a lead, startup style organisation with a varied and broad list of responsibilities to achieve the common goal
This is a high-profile executive role offering the chance to lead global functions in a company with a strong commercial footprint and ambitious growth plans. You’ll be instrumental in shaping regulatory strategy and driving patient impact across international markets.
Due to the nature of the role, candidates must hold valid right to work in the UK. THIS IS A REMOTE, FULL TIME EMPLOYED POSITION.