Director, CMC Regulatory

BioSpace; Philadelphia (Philadelphia County); On-site; USD 148,500 - 217,800; Full time

Benefits offered by this job

401(k) and pension

Comprehensive health benefits

Vacation

Employee assistance program

Job summary

A leading pharmaceutical company is seeking a qualified Director, CMC Regulatory to lead global regulatory CMC strategies for diagnostic radiopharmaceutical products. You will be responsible for generating country-specific regulatory strategies and leading submissions globally. The ideal candidate will have over 10 years in drug development, including direct CMC regulatory experience. A BS Degree in a related field is required, with an advanced degree preferred. Competitive compensation and benefits are offered, with an expected salary range of $148,500 to $217,800.

Qualifications

• Minimum of 10 years in pharmaceutical drug development and/or pharmaceutical manufacturing.
• At least five years of direct CMC regulatory experience.

Responsibilities

• Generate and execute country-specific CMC regulatory strategies.
• Lead global CMC regulatory submissions including authoring and finalization.
• Respond to regulatory agency questions globally.
• Review change controls and technical documents from a CMC regulatory perspective.

Skills

CMC regulatory experience

Technical writing skills

Leadership skills

Communication skills

Education

BS Degree in science, engineering, or a related field

Advanced degree

Tools

MS Office

Job description

Director, CMC Regulatory

Join Lilly to lead the development and implementation of global regulatory CMC strategies for our Avid diagnostic radiopharmaceutical products. The role focuses on delivering all relevant CMC regulatory submissions worldwide.

Position Overview

The Director, CMC Regulatory will leverage CMC technical knowledge and regulatory science expertise to drive global regulatory CMC strategies for Lilly | Avid diagnostic radiopharmaceutical products. This includes the delivery of all relevant CMC regulatory submissions globally.

Responsibilities

• Responsible for the generation and execution of country-specific CMC regulatory strategies for investigational and commercial radiopharmaceutical products.
• Lead global CMC regulatory submissions including authoring, review, and finalization.
• Lead and contribute to responses to regulatory agency questions globally.
• Review change controls to assess country-specific CMC regulatory impact.
• Review technical documents including testing protocols, technical reports, and CMO procedures and specifications from a CMC regulatory perspective.
• Demonstrate an in-depth understanding of CMC regulatory requirements across multiple regions.
• Monitor and evaluate new regulations, guidance, regulatory changes, and trends pertaining to CMC regulatory and communicate with internal stakeholders.
• Managing a small group of CMC regulatory professionals.
• Perform other duties as assigned.

Basic Qualifications

• BS Degree in science, engineering, or a related field.
• Minimum of 10 years in pharmaceutical drug development and/or pharmaceutical manufacturing with a minimum of five years of direct CMC regulatory experience.

Additional Skills/Preferences

• Advanced degree strongly preferred.
• PET drug experience preferred.
• Ability to manage people and drive engagement among teams.
• Demonstrated strong written, spoken and presentation communication skills.
• Excellent technical writing skills.
• Ability to plan and align.
• Ability to adapt to change and be a nimble learner.
• Ability to ensure accountability of oneself and others.
• Demonstrated leadership behaviors and negotiation and influence skills.
• Creative thinking and ability to cultivate innovation.
• Demonstrated attention to detail.
• Excellent MS Office skills.

Compensation and Benefits

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $148,500 - $217,800. Full-time employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k), pension, vacation, medical, dental, vision, prescription drug benefits, flexible benefits such as healthcare and dependent day care flexible spending accounts, life insurance and death benefits, certain time off and leave of absence benefits, and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs).

Equal Employment Opportunity

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.