Overview
We are seeking a Senior Regulatory CMC Project Lead to oversee the global regulatory strategy for a late-stage small molecule development program. This interim position involves driving the preparation for Marketing Authorisation applications and working closely with cross-functional teams and regulatory leaders to ensure compliance and successful delivery of registration dossiers. The role is oriented towards professionals who thrive in strategic leadership and project delivery within a regulatory context.
Responsibilities
- Lead the development of the global CMC regulatory strategy for a late-stage small molecule asset.
- Manage the preparation and submission processes for Marketing Authorisation applications.
- Collaborate with cross-functional teams to ensure alignment on regulatory objectives.
- Develop and execute agency interaction strategies to support regulatory submissions.
- Identify and manage regulatory risks throughout the project lifecycle.
- Provide strategic insights to influence critical development decisions.
- Engage with senior stakeholders to communicate regulatory progress and challenges.
- Leverage knowledge of international regulations to enhance submission success.
Requirements
- Minimum of 10 years' experience in Regulatory Affairs CMC focusing on late-stage small molecule development.
- Proven track record in leading CMC components for global Marketing Authorisation submissions.
- Strong understanding of FDA, EMA, and ICH regulatory requirements.
- Experience with regulatory strategies in international markets, including China and Japan.
- Demonstrated ability to lead complex, cross-functional teams.
- Excellent project leadership and stakeholder management skills.
- Strong analytical, problem-solving, and risk assessment abilities.
- Life Sciences degree required; MSc, PharmD, or PhD preferred.