Senior Director, Small Molecule CMC Regulatory (Hybrid)

BioSpace; Cambridge (MA); Hybride; USD 242 000 - 314 000; Plein temps

Avantages offerts par ce poste

Hybrid work schedule

Discretionary annual bonus

Long-term incentive/equity

Résumé du poste

Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC – Small Molecules to provide strategic leadership across the full CMC lifecycle for immunology/inflammation programs. You will align with Process Development, Analytical Sciences, Quality, and external CMOs to ensure compliant, timely regulatory filings with FDA, EMA, and other global authorities.

The role requires a minimum of 12 years in CMC regulatory affairs, advanced degree in related fields, and a proven track record of

Qualifications

• Advanced degree in organic chemistry, pharmaceutical sciences, analytical chemistry, or related field preferred.
• 12+ years of CMC regulatory affairs experience in pharma/biotech preferred.
• Experience leading FDA/EMA CMC meetings and responding to deficiency letters.

Responsabilités

• Develop and lead CMC regulatory strategy for small molecule assets through IND/CTA, NDA, and post‑approval.
• Prepare CMC sections of regulatory submissions in ICH CTD format with quality and regulatory defensibility.
• Lead Health Authority interactions for CMC topics and manage post‑approval changes and technology transfers.
• Provide regulatory interpretation of ICH/Q8‑Q12 and advise on design space and control strategy.
• Establish CMC SOPs, templates, and document management workflows for small molecules.

Connaissances

Regulatory leadership

Cross-functional collaboration

Regulatory submissions

FDA/EMA interactions

Formation

PhD in organic chemistry / pharmaceutical sciences

MS or PharmD in related field

Outils

ICH CTD/eCTD familiarity

Regulatory guidance expertise (FDA/EMA)

Description du poste

Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC – Small Molecules to provide strategic leadership across the full CMC lifecycle for immunology/inflammation programs. You will align with Process Development, Analytical Sciences, Quality, and external CMOs to ensure compliant, timely regulatory filings with FDA, EMA, and other global authorities.

The role requires a minimum of 12 years in CMC regulatory affairs, advanced degree in related fields, and a proven track record of