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Director & Chief Compliance Officer

1 month ago

United Kingdom Warman O'Brien Full time

Director, Regulatory Affairs
Role Overview:

Responsible for leading regulatory strategy and execution across global markets to support product development, registration, and lifecycle management. Ensures compliance with evolving regulatory frameworks and engages with health authorities to facilitate approvals and post-marketing obligations.

Key Responsibilities:

Develop and implement comprehensive regulatory strategies to optimize product registration, approval pathways, and lifecycle management.
Provide regulatory oversight for clinical trial applications (CTAs), investigational new drug (IND) submissions, and marketing authorization applications (MAAs, NDAs, BLAs).
Conduct regulatory intelligence assessments and ensure proactive adaptation to evolving regulatory landscapes.
Act as primary liaison with global health authorities (e.g., FDA, EMA, MHRA), leading regulatory interactions, negotiations, and advisory meetings.
Ensure adherence to GxP requirements, including GMP, GCP, pharmacovigilance, and promotional compliance.
Drive regulatory due diligence for in-licensing and business development initiatives.

Qualifications & Experience:

Minimum 10 years of regulatory affairs experience in pharmaceuticals/biotech, with at least 3 years in a leadership capacity.
Advanced degree in life sciences (Pharmacy, Chemistry, Biochemistry); postgraduate qualifications preferred.
Expertise in regulatory pathways for hematology, women’s health, gastroenterology, or nephrology preferred.
Proven track record in global regulatory submissions, approvals, and lifecycle management.