Senior Director, Regulatory CMC — Global NDA/IND Strategy

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company; Boston (MA); On-site; USD 185,000 - 250,000; Full time

Benefits offered by this job

401(k) plan

Health insurance

Dental coverage

Vision insurance

Life insurance

Paid time off

Wellness program

Job summary

Centessa Pharmaceuticals in the US seeks a Senior Director, Regulatory CMC to provide strategic and operational leadership for Regulatory CMC activities across small molecule programs.

You will lead CMC initiatives, develop global regulatory strategies, partner with stakeholders, and oversee CMC submissions including INDs, NDAs, and variations. This role demands extensive experience with outsourced development and manufacturing and strong regulatory expertise.

Qualifications

• Master's degree in Chemistry, Pharmaceutical Sciences, or a related discipline.
• Minimum of 12 years in pharmaceutical industry, including at least 5 years in Regulatory CMC roles supporting small molecule programs.
• Recent, direct experience leading Regulatory CMC activities for late-stage development programs, including NDA-enabling activities and marketing application submissions.

Responsibilities

• Develop and execute integrated Regulatory CMC strategies from preclinical through late-stage clinical development and regulatory submissions.
• Provide strategic leadership across drug substance, drug product, analytical development, manufacturing, and control activities.
• Serve as Regulatory CMC expert on cross-functional program teams, aligning CMC plans with clinical, regulatory, quality, and business objectives.
• Provide regulatory guidance to CMC and program teams, driving decisions on development plans and lifecycle management.

Skills

Regulatory CMC leadership

IND/NDA submissions

CDMO management

FDA/ICH/EMA knowledge

Cross-functional leadership

Oroxin/CNS experience

Education

Master's degree in Chemistry/ Pharmaceutical Sciences

PharmD or PhD preferred

Job description

Centessa Pharmaceuticals in the US seeks a Senior Director, Regulatory CMC to provide strategic and operational leadership for Regulatory CMC activities across small molecule programs.

You will lead CMC initiatives, develop global regulatory strategies, partner with stakeholders, and oversee CMC submissions including INDs, NDAs, and variations. This role demands extensive experience with outsourced development and manufacturing and strong regulatory expertise.