Associate / Manager - CMC Regulatory and IMP Manufacturing Operations

Hispanic Alliance for Career Enhancement; Philadelphia (Philadelphia County); On-site; USD 61,000 - 143,000; Full time

Job summary

An established industry player seeks a dedicated individual to support CMC regulatory operations. This role involves managing regulatory documents, ensuring compliance, and preparing global regulatory submissions. The ideal candidate will have a scientific background and at least one year of relevant experience. Join a dynamic team committed to making a difference in healthcare and enjoy a comprehensive benefits package, including health insurance and a 401(k). If you're organized, detail-oriented, and thrive in fast-paced environments, this opportunity is perfect for you!

Benefits

401(k)

Health Insurance

Paid Time Off

Well-being Programs

Qualifications

• 1+ year of experience in pharmaceutical development or CMC regulatory.
• Strong communication and technical writing skills.

Responsibilities

• Support CMC change management and ensure compliance with quality systems.
• Prepare and submit global CMC regulatory dossiers.

Skills

Organizational Skills

Communication Skills

Technical Writing

MS Office Proficiency

Adaptability

Education

Bachelor's Degree in a Scientific Discipline

Job description

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 worldwide work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and contribute to our communities through philanthropy and volunteerism. We prioritize our efforts and put people first, seeking individuals committed to making life better globally.

Organization Overview:

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 35,000 employees worldwide work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and contribute to our communities through philanthropy and volunteerism. We prioritize our efforts and put people first, seeking individuals committed to making life better globally.

Responsibilities:

• Support CMC change management, including change control issuance and assessments, ensuring compliance with quality systems.
• Coordinate CMC regulatory operations, manage regulatory documents, and maintain submission information in the RIM system.
• Prepare, review, and submit global CMC regulatory dossiers and respond to information requests per strategies.
• Author, revise, and review technical documentation such as testing protocols and SOPs.
• Participate in cross-functional teams to align global regulatory strategies with development and commercial plans.
• Support infrastructure tools, procedures, and systems for CMC regulatory and development activities.
• Stay current with global CMC regulatory guidelines.
• Perform other duties as assigned.

Basic Requirements:

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

Additional Skills/Preferences:

• Organized and detail-oriented.
• Strong communication skills and ability to work in global multidisciplinary teams.
• Excellent technical writing skills.
• Ability to prioritize and handle multiple tasks independently.
• Adaptability to change and fast-paced environments.
• Proficiency in MS Office.

Additional Information:

• Willingness to travel within the USA and globally up to 10%.

Lilly is committed to accommodating individuals with disabilities. For assistance with the application process, please complete the workplace accommodation request form.

We are an Equal Employment Opportunity employer and do not discriminate based on age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or other protected classes.

Our employee resource groups (ERGs) support diverse communities and are open to all employees. Learn more about our ERGs.

Compensation for this role ranges from $61,500 to $143,000, depending on experience, education, and location. Benefits include a comprehensive package such as 401(k), health insurance, paid time off, and well-being programs.