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Associate Director Regulatory Writer
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Job Title: Associate Director, Regulatory Writing
Location: UK (Remote | Hybrid available for those near London, Manchester, or Macclesfield)
Employment Type: Full-time, Permanent
We're partnering with a leading medical communications organisation to appoint an experienced Associate Director, Regulatory Writing.
This is a strategic leadership opportunity for an accomplished regulatory writer who can look beyond document delivery and partner with clients on broader development and regulatory objectives. You'll provide scientific and strategic guidance, oversee complex programmes, and help shape regulatory communication strategies across multiple projects.
What you'll be doing:
- Provide strategic leadership across regulatory writing projects, supporting clients throughout development and registration programmes
- Lead authoring and oversight of complex regulatory documents while ensuring quality, consistency, and compliance
- Partner directly with clients, providing scientific and strategic consultation on regulatory communication plans and submission strategies
- Mentor and develop medical writers, fostering technical excellence and best practices across the team
- Contribute to business growth, client retention, and the ongoing development of regulatory writing capabilities
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What we're looking for:
- Bachelor's degree in Life Sciences or a related scientific field, with MSc, PhD, PharmD, or equivalent preferred
- 5 to 6+ years of medical or regulatory writing experience within medical communications, CRO, or pharmaceutical environments
- Demonstrated expertise in developing high-quality regulatory documentation across multiple stages of development
- Ability to provide strategic insight and understand broader regulatory and development objectives beyond individual deliverables
- Strong leadership, client management, and stakeholder engagement skills
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Why consider this opportunity?
- Strategic, client-facing role with significant influence and visibility
- Opportunity to work with global pharmaceutical and biotechnology clients on high-impact programmes
- Fully remote flexibility with hybrid office options where preferred
- Clear opportunity to mentor, lead, and shape team development
- Join a growing organisation with strong career progression and long-term growth opportunities
Interested or know someone who could be a great fit? Feel free to reach out directly or apply!
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