At a Glance
- Tasks: Lead regulatory strategy for a key small molecule programme and prepare for Marketing Authorisation submission.
- Company: Innovative global pharmaceutical organisation with a focus on late-stage development.
- Benefits: Remote work, competitive salary, and the chance to influence critical development decisions.
- Other info: Dynamic role with opportunities for collaboration across international markets.
- Why this job: Shape global CMC regulatory strategy and make a real impact on patient access.
- Qualifications: 10+ years in Regulatory Affairs CMC with strong project leadership skills.
The predicted salary is between 63000 - 77000 £ per year.
- Senior Regulatory CMC Project Lead - Interim
- Late-Stage Small Molecule Development | Global Regulatory Strategy | MAA Preparation
- 6 months – renewable
- Remote
- If based in UK, Outside IR35
Are you a seasoned Regulatory CMC professional looking to take ownership of a high-profile late-stage asset approaching registration?
We're supporting an innovative global pharmaceutical organisation seeking a
Senior Regulatory CMC Project Lead to drive regulatory strategy for a key small molecule programme as it advances towards Marketing Authorisation submission.
This is a highly visible position where you'll play a central role in shaping global CMC regulatory strategy, influencing critical development decisions, and working alongside senior scientific, quality, supply chain and regulatory leaders across multiple geographies.
The Opportunity
You'll become the strategic Regulatory CMC lead for a late-stage small molecule asset, taking ownership of the global CMC regulatory roadmap and ensuring successful preparation and delivery of the registration dossier.
Working at the heart of a complex global development programme, you'll collaborate with cross-functional teams, lead agency interaction strategies, manage regulatory risk, and help accelerate the path to patients through innovative and pragmatic regulatory approaches.
This is an excellent opportunity for someone who enjoys combining technical CMC expertise with strategic leadership, stakeholder engagement, and regulatory project delivery.
What We're Looking For
- 10+ years' experience within Regulatory Affairs CMC – focused specifically on small molecule late stage development.
- Proven experience leading the CMC components of global Marketing Authorisation submissions.
- Strong understanding of late-stage development and registration activities for small molecule products.
- Experience developing and executing global regulatory strategies.
- Deep knowledge of FDA, EMA and ICH regulatory requirements.
- Exposure to international markets such as China, Japan, Brazil and Canada would be highly advantageous.
- Demonstrated success working within complex, cross-functional global development teams.
- Excellent project leadership, communication and stakeholder management skills.
- Strong analytical, problem-solving and risk management capabilities.
- Life Sciences degree required; MSc, Pharm D or Ph D preferred.
CMC, regulatory, MAA, late, phase, three, development, small, molecule, API, BLA, stage, interim, freelance, contract
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