Overview As a Regulatory CMC Lead for the synthetic moiety of ADCs and bio-conjugates, you steer global regulatory strategies and milestones from development through lifecycle. You will integrate CMC plans with the targeting component and conjugation processes, ensuring compliant dossier content and timely submissions. You'll collaborate across functions to manage regulatory filings and change controls, driving mature, phase-appropriate strategies. This role blends science leadership with regulatory excellence to enable safe, effective bio-conjugates.
Compensation / Benefits- medical, dental, vision insurance
- 401(k) retirement benefits
- paid holidays and vacation
- sick days
- annual bonus
- long-term incentive eligibility
Responsibilities- Lead regulatory CMC strategy for drug-linkers and chemically synthesized moieties in ADCs and bio-conjugates
- Deliver global regulatory milestones across development and post-approval lifecycle
- Assess global CMC requirements, identify risks, and develop mitigation plans
- Integrate regulatory strategy with conjugation processes, targeting components, and drug products
- Prepare and execute CMC documentation (INDs, IMPDs, BLA/MAA, variations, responses)
- Manage change controls and filing strategies with a compliance-focused mindset
- Collaborate with cross-functional teams and external partners to align dossier content and regulatory expectations
Key requirements- At least 5 years of Regulatory CMC or related pharmaceutical development experience
- Experience in small molecules or chemically synthesized modalities including process chemistry, analytical development, manufacturing, quality, or CMC product development
- Experience supporting CMC regulatory submissions or health authority interactions
- Understanding of global regulatory requirements and lifecycle management
- Experience with external development or manufacturing partners (preferred)
- Adaptability
- Detail-oriented
- Interpersonal relationships
- Regulatory CMC leadership
- eCTD
- Drug-linkers and bio-conjugates knowledge
