Now Hiring: Associate Director – Global Regulatory Strategy (Neurology Focus)
Hertfordshire, UK (Hybrid) | Global Scope | 20–30% Travel
We're supporting a global pharmaceutical organisation in the search for an experienced Regulatory Affairs leader to shape and drive global strategy across a Neurology portfolio.
Core Responsibilities:
* Lead EU and/or Global Regulatory Strategy across development and post-approval assets
* Oversee CTA/MAA submissions, ensuring quality, compliance, and timely delivery
* Act as primary interface with global health authorities (EMA, MHRA, others)
* Lead Scientific Advice interactions and author key regulatory strategy documents
* Drive cross-functional alignment across clinical, regulatory, and commercial teams
* Own product lifecycle management strategy and execution
What we're looking for (key priorities):
* Exceptional communication skills (top priority) – clear, concise written and verbal communication is critical
* Strong examples of agency interactions and regulatory correspondence will be highly valued
* Proven Regulatory Affairs experience in pharma/biotech, ideally with both development + marketed products
* Strong exposure to CTA and MAA submissions (ideally having led MAAs)
* Experience leading health authority meetings (EMA strongly preferred, MHRA or other agencies also valued)
* Demonstrated ability to respond quickly and effectively to regulatory authority queries
* Experience in Scientific Advice and Paediatric Investigation Plans (PIPs)
* Neurology experience desirable but not essential – strong broader regulatory backgrounds welcome
* Proven success working in a global matrix environment and leading cross-functional teams
Why this role?
* Strategic leadership position shaping global regulatory direction in a key therapeutic area
* High visibility role working across UK, US, and Japan teams
* Hybrid working model with global exposure and influence
* Opportunity to impact innovative medicines from development through lifecycle
We're looking for someone who thrives in high-stakes regulatory environments, communicates with clarity and confidence, and can lead strategy while navigating global health authority expectations.
If this sounds like your next move, please get in touch or apply directly.
Reach out now!
Tshering Sherpa