Associate Director CMC Regulatory

Job Title: Associate Director, CMC Regulatory

This role leads Chemistry, Manufacturing, and Controls (CMC) regulatory activities with a strong nonclinical focus, supporting faculty and staff on product development and regulatory strategy. The Associate Director, CMC Regulatory provides expert guidance on regulatory requirements for animal studies and clinical applications, prepares and supports submissions to health authorities, and partners closely with clinical research teams to advance innovative therapies, including gene therapies and biologics. The position offers the opportunity to work as part of an internal clinical research organization, gain broad exposure across multiple therapeutic areas, and contribute to cutting-edge research within a highly collaborative academic medical environment.

Responsibilities

• Consult with faculty and staff on product development and regulatory topics with a primary focus on nonclinical and CMC aspects.
• Provide regulatory guidance and support for animal studies, ensuring alignment with applicable regulations and institutional policies.
• Lead or support the preparation, review, and coordination of regulatory submissions, including INDs, IDEs, and related clinical applications.
• Interface with health authorities, particularly the FDA, to support regulatory interactions, responses to inquiries, and submission follow-up.
• Develop, review, and maintain regulatory documentation such as protocols, IND sections, and supporting technical reports.
• Ensure regulatory strategies and submissions comply with FDA clinical trial regulations and guidance, including GMP, GLP, GVP, and GCP.
• Collaborate with internal clinical research units, including compliance, regulatory support, contracting, operations, and finance, to facilitate successful clinical trial execution.
• Provide internal consultation on regulatory pathways for investigator-initiated and industry-sponsored clinical trials across multiple therapeutic areas.
• Work independently on assigned projects, managing timelines, deliverables, and communication with stakeholders.
• Contribute to ongoing education and training initiatives related to regulatory requirements and best practices.
• Participate in regular internal meetings and training sessions to stay current on evolving regulatory expectations and emerging scientific areas such as gene therapy and biologics.
• Support continuous improvement of regulatory processes and documentation standards within the organization.

Essential Skills

• 7–10 years of experience in regulatory affairs or a closely related field.
• Bachelor’s or Master’s degree in a relevant scientific discipline; PhD preferred.
• Demonstrated experience with IND and clinical application preparation and submission.
• Experience supporting or working on animal studies in a regulatory or nonclinical context.
• Experience working with health authorities, specifically the FDA.
• Knowledge and experience with FDA clinical trial regulations and guidance, including GMP, GLP, GVP, and GCP.
• Ability to consult comfortably with faculty and staff on product development and regulatory topics with a nonclinical focus.
• Proven ability to work independently on projects and manage multiple priorities.
• Strong scientific and regulatory writing skills, including preparation of protocols and submission documents.
• Proficiency with core regulatory concepts such as INDs, IDEs, and clinical trial protocols.

Additional Skills & Qualifications

• Experience with gene therapy and biologics, or strong interest in working with cutting-edge modalities.
• Experience in supporting both industry-sponsored and investigator-initiated clinical studies.
• Familiarity with internal clinical research office structures, including compliance, regulatory support, contracting, operations, and finance.
• Interest in ongoing professional development through structured training and weekly educational meetings.
• Ability to communicate complex regulatory concepts clearly to diverse scientific and clinical stakeholders.
• Strong organizational skills and attention to detail in managing regulatory documentation and timelines.

This is a Contract to Hire position based out of Philadelphia, PA.

The pay range for this position is $45.00 - $55.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Philadelphia,PA.

This position is anticipated to close on Jun 26, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.