Associate / Manager - CMC Regulatory and IMP Manufacturing Operations

Society for Conservation Biology; Philadelphia (Philadelphia County); On-site; USD 61,000 - 143,000; Full time

Job summary

A leading company in the healthcare sector seeks an Associate/Manager for CMC Regulatory and IMP Manufacturing Operations. The role involves managing regulatory submissions, coordinating documentation, and supporting change management in a dynamic environment. Candidates should have a scientific background, strong communication skills, and the ability to thrive in fast-paced settings. Competitive salary and comprehensive benefits are offered.

Benefits

401(k)

Pension

Health insurance

Flexible spending

Life insurance

Paid time off

Wellness programs

Qualifications

• Minimum of 1 year experience in pharmaceutical development or related fields.

Responsibilities

• Support CMC change management and ensure compliance with quality systems.
• Manage preparation and submission of global CMC regulatory dossiers.
• Participate in cross-functional teams for regulatory strategies.

Skills

Organized

Detail-oriented

Strong communication

Technical writing

Adaptability

Education

Bachelor's degree in a scientific discipline

Tools

MS Office

Job description

Associate / Manager - CMC Regulatory and IMP Manufacturing Operations

Employer: Eli Lilly and Company

Location: Philadelphia, Pennsylvania, US

Salary: Competitive

Closing date: May 11, 2025

Sector: Consultancy/Private Sector

Field: Conservation science

Discipline: Administration/Operations, Project Management

Salary Type: Salary

Employment Type: Full time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and give back through philanthropy and volunteerism. We prioritize putting people first and are looking for dedicated individuals who want to make a difference.

Organization Overview:

At Lilly, we are committed to making life better globally. With 35,000 employees worldwide, we focus on discovering and delivering medicines that change lives, understanding and managing diseases, and supporting our communities. We seek individuals passionate about improving lives.

Responsibilities:

• Support CMC change management, including change control issuance and assessments, ensuring compliance with quality systems.
• Coordinate regulatory submission timelines, manage documents, prepare content plans, and maintain submission info within RIM systems.
• Manage preparation, review, and submission of global CMC regulatory dossiers and responses to information requests.
• Author, revise, and review technical documents such as testing protocols, reports, and SOPs.
• Participate in cross-functional teams to align global regulatory strategies with CMC development and commercial plans.
• Support infrastructure tools, procedures, and systems for CMC regulatory activities.
• Stay current with global regulatory guidelines applicable to CMC.
• Perform other duties as assigned.

Basic Requirements:

• Bachelor's degree in a scientific discipline.
• Minimum of 1 year experience in pharmaceutical development, manufacturing, CMC regulatory, project management, or related fields.

Preferred Skills:

• Organized and detail-oriented.
• Strong communication skills for global team collaboration.
• Excellent technical writing skills.
• Ability to prioritize and handle multiple tasks.
• Self-sufficient with minimal supervision.
• Adaptability to change and fast-paced environments.
• Proficient in MS Office.

Additional Information:

• Willingness to travel within the USA and internationally (~10%).

Lilly is committed to diversity and inclusion. If accommodations are needed during the application process, please complete the workplace accommodation request form.

We are an Equal Opportunity Employer, valuing diversity and inclusion across all employment practices.

Our Employee Resource Groups (ERGs) support diverse communities and are open to all employees. Learn more about our ERGs and initiatives.

Compensation for this role ranges from $61,500 to $143,000, depending on experience, education, and location. Benefits include a 401(k), pension, health insurance, flexible spending, life insurance, paid time off, and wellness programs.

#WeAreLilly

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