Senior Director, Small Molecule CMC Regulatory

Beeline Medicines; Boston; Hybrid; PHP 14,892,000 - 19,292,000; Full time

Benefits offered by this job

Hybrid work schedule

Competitive compensation

On-site 2 days per week

Healthcare benefits

Job summary

Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC – Small Molecules to lead regulatory strategy across all CMC activities for the I&I portfolio. You will partner with Technical Development, Analytical Sciences, and Quality to ensure submissions meet FDA/EMA expectations and lifecycle requirements.

You will drive Health Authority interactions, oversee global CTD submissions, and shape post-approval change management while working in a dynamic, collaborative, hybrid

Qualifications

• Advanced degree with strong regulatory science focus.
• Extensive experience leading CMC regulatory strategy for small molecules.
• Experience authoring and defending submissions to FDA/EMA and other Health Authorities.

Responsibilities

• Lead CMC regulatory strategy for small molecule assets from IND/CTA through NDA and lifecycle management.
• Prepare and oversee CMC sections of global regulatory submissions (INDs, CTAs, NDAs, MAAs, variances) in ICH CTD/eCTD format.
• Serve as regulatory partner to Technical Development, Process Chemistry, Analytical, and Quality teams.

Skills

CMC regulatory strategy

Regulatory leadership

Global submissions

ICH CTD/eCTD

Health Authority meetings

Education

Advanced degree (PhD, MS, or PharmD) in pharmaceutical sciences or organic chemistry

Job description

Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC – Small Molecules to lead regulatory strategy across all CMC activities for the I&I portfolio. You will partner with Technical Development, Analytical Sciences, and Quality to ensure submissions meet FDA/EMA expectations and lifecycle requirements.

You will drive Health Authority interactions, oversee global CTD submissions, and shape post-approval change management while working in a dynamic, collaborative, hybrid