Senior Director, Regulatory CMC (remote)

Ladders; United States; À distance; USD 176 000 - 284 000; Plein temps

Avantages offerts par ce poste

401(k) and pension plan

Medical, dental, vision, and Rx

Flexible spending accounts

Résumé du poste

Ladders is seeking a Senior Director, Regulatory CMC to lead regulatory strategy for small molecule programs from preclinical stages through global submissions. This remote leadership role partners with development, analytical, manufacturing, and program teams to ensure CMC plans are aligned, compliant, and ready for regulatory review.

You will guide risk-based decisions across the product lifecycle and manage external manufacturing relationships.

Qualifications

• Master's degree or higher in a relevant field with strong regulatory CMC background.
• 12+ years in pharma with at least 5+ years in Regulatory CMC for small molecules.
• Experience leading NDA submissions and late-stage development programs.
• Proven ability to manage external manufacturing partners and CDMOs.
• Deep knowledge of cGMP, ICH guidelines, and global regulatory expectations.

Responsabilités

• Develop and implement Regulatory CMC strategies from preclinical to submission.
• Provide strategic leadership across drug substance, product, and analytics.
• Lead cross-functional teams ensuring alignment of CMC plans with program goals.
• Guide risk-based lifecycle decisions and regulatory strategy for global filings.
• Lead preparation and approval of CMC content for global submissions and responses.
• Monitor regulatory changes and integrate innovative approaches to development.
• Manage external partners, including CDMO selection and oversight.

Connaissances

Regulatory leadership

Cross-functional collaboration

Regulatory strategy

IND/NDA filings

CDMO management

Formation

Master's degree in Chemistry, Pharmaceutical Sciences, or a related field

PharmD or PhD preferred

Description du poste

For our client, we are seeking a Senior Director, Regulatory CMC to join the team of a leader in the Pharmaceuticals & Biotech space.

In this remote leadership role, you will shape Regulatory CMC strategy for small molecule programs from preclinical stages through global submission. You will partner closely with development, analytical, manufacturing, and program teams to ensure CMC plans are aligned, compliant, and ready for regulatory review. This position also plays a key role in managing external manufacturing relationships and guiding risk-based decisions across the product lifecycle.

Location: Remote

Compensation: $175,500 – $283,800 annually

Responsibilities

• Develop and execute Regulatory CMC strategies for small molecule programs from preclinical development through regulatory submission.
• Provide strategic leadership across drug substance, drug product, and analytical development activities.
• Serve as the Regulatory CMC expert on cross-functional teams, aligning CMC plans with broader program objectives.
• Guide CMC and program teams on regulatory risk and lifecycle management decisions.
• Lead preparation and approval of CMC content for global regulatory submissions and agency responses.
• Monitor global regulatory changes and incorporate innovative approaches to support efficient product development.
• Manage external partners, including CDMO selection and oversight, ensuring compliance and readiness.

Qualifications

• Master's degree in Chemistry, Pharmaceutical Sciences, or a related field; PharmD or PhD preferred.
• 12+ years of pharmaceutical industry experience, including 5+ years in Regulatory CMC roles for small molecules.
• Recent leadership experience in late-stage development programs and NDA submissions.
• Proven track record in authoring and managing CMC regulatory filings, including INDs and NDAs.
• Strong knowledge of small molecule development, analytical processes, and manufacturing principles.
• Extensive experience managing CDMOs and external manufacturing partners.
• Thorough understanding of cGMP, ICH guidelines, and global Regulatory CMC expectations.

Benefits

• Eligibility for a company-sponsored 401(k) and pension plan.
• Comprehensive medical, dental, vision, and prescription drug benefits.
• Flexible spending accounts for healthcare and dependent care.
• Life insurance and death benefits.
• Vacation benefits and various leave of absence options.
• Well-being benefits including employee assistance programs and fitness initiatives.

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.