Planet Pharma
Associate Director, Global Regulatory Strategy
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Associate Director, Global Regulatory Strategy – Neurology
A leading global pharmaceutical organisation is seeking an experienced Associate Director, Global Regulatory Strategy to join their Neurology team and play a key role in shaping regulatory strategy across development and post-approval programmes.
This is an exciting opportunity for a senior regulatory professional who enjoys operating strategically, influencing cross-functional teams, and working closely with global stakeholders. The successful candidate will have the opportunity to contribute to regulatory direction, lead health authority interactions, and represent the organisation externally within the regulatory community.
Key responsibilities:
- Develop and execute global regulatory strategies for products within the Neurology portfolio
- Act as a Global or EU Regulatory Lead across development and established products
- Lead regulatory submission activities, including CTA and MAA-related activities
- Prepare regulatory strategies, agency responses, and briefing documents
- Lead interactions with global health authorities, including EMA and European agencies
- Provide regulatory input into clinical development plans and lifecycle management strategies
- Partner with cross-functional teams across Clinical, Safety, CMC, Medical and Commercial functions
- Represent Regulatory Strategy in internal and external forums
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What we’re looking for:
- Extensive pharmaceutical Regulatory Affairs experience within a global environment
- Strong experience supporting clinical development programmes and regulatory strategy
- Experience with CTA and MAA submissions (ideally having led an MAA)
- Experience interacting with health authorities, particularly EMA/MHRA
- Proven ability to lead regulatory meetings and influence cross-functional teams
- Excellent written and verbal communication skills, with the ability to develop high-quality regulatory documents and responses
- Experience working across global teams and matrix environments
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Desirable experience:
- Experience across both development and post-approval products
- Experience with Scientific Advice and Paediatric Investigation Plans
This role offers significant visibility, access to senior stakeholders, and the opportunity to influence regulatory strategy within an innovative global organisation.
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