Job Title: Senior Director, Global Regulatory Affairs – Chemistry Manufacturing Controls (CMC)
Company: Eikon Therapeutics
Location: Jersey City, NJ (Hybrid – minimum 3 days onsite/week)
Job Type: Full-time
Salary Range: $239,000 – $261,250 (plus bonus & equity)
About the Company
Eikon Therapeutics is a cutting-edge biotech company leveraging Nobel Prize-winning single-molecule microscopy to accelerate drug discovery and unlock challenging drug targets by observing protein movement in real time.
Role Summary
As Senior Director, Global Regulatory Affairs – CMC, you will lead global regulatory strategies related to Chemistry, Manufacturing, and Controls, supporting INDs, NDAs/MAAs, and ongoing development activities. This role requires deep regulatory CMC expertise and strategic leadership across pre- and post-approval settings, including oversight of filings for new chemical entities (NCEs) and biologics.
Key Responsibilities
Lead the design and execution of global CMC regulatory submission strategies
Oversee preparation of IND, CTA, NDA, and MAA CMC documentation
Ensure compliance with global regulatory standards and authority guidance
Coordinate with CMC teams to ensure timely, high-quality document delivery
Respond to CMC information requests from health authorities
Conduct CMC impact assessments and change control reviews
Lead CMC components of regulatory meetings and submissions
Ensure proper archiving of CMC correspondence and commitments
Monitor regulatory trends and ensure internal teams remain compliant and informed
Mentor team members and manage vendors where applicable
Qualifications
Postgraduate degree with 12+ years or bachelor's degree with 15+ years in Regulatory Affairs, specializing in CMC
Experience in biologics and successful NDA/MAA submissions for NCEs
Deep understanding of global CMC regulatory requirements and documentation
Strong leadership, project management, and communication skills
Experience managing cross-functional teams and/or direct reports preferred
Proven ability to influence cross-functional teams and drive strategic outcomes
Compensation & Benefits
Competitive salary plus bonus and equity
401(k) with company match
Medical (95%), dental & vision (100%) premiums covered
Mental health and wellness support
Paid time off, holidays, and weeklong summer/winter shutdowns
Enhanced parental leave
Life and AD&D insurance (100% covered)
Daily subsidized lunch onsite
Diversity & Inclusion
Eikon Therapeutics is committed to fostering an inclusive and diverse workplace. All qualified applicants will be considered without regard to protected characteristics.
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