Global CMC Regulatory Lead for INDs & CTAs

Pace Analytical Life Sciences; Maryland; Remote; USD 97,000 - 138,000; Full time

Benefits offered by this job

Medical coverage

Dental & Vision

401K

Life Insurance

Disability coverage

Paid time off

HSA

Tuition reimbursement

Employee Assistance

Parental leave

ID theft protection

Job summary

Pace Analytical Life Sciences is seeking a senior regulatory expert to lead CMC regulatory strategies for global programs. This role focuses on authoring and coordinating INDs, IMPDs, CTAs, amendments and annual reports to ensure compliance with FDA, EMA and ICH guidelines.

You will advise clients, manage multiple deliverables in a fast-paced environment and contribute to the development of efficient regulatory processes and templates for streamlined submissions.

Qualifications

• Minimum 10+ years of experience in CMC/regulatory affairs.
• Hands-on experience authoring CMC sections for INDs, IMPDs, CTAs, amendments.
• Strong knowledge of FDA, EMA, and ICH guidelines.
• Excellent attention to detail, technical writing, organizational and communication skills.
• Ability to manage multiple deliverables and timelines in a fast-paced environment.
• Proficiency with regulatory document management systems.

Responsibilities

• Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports.
• Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols.
• Support regulatory interactions by preparing responses to CMC-related questions from FDA, EMA, PMDA, and other global health authorities.
• Prepare and lead regulatory interactions for CMC regulatory strategies to support clinical trial initiation and advancement.
• Contribute to the development of templates, processes, and workflows to support efficient and compliant CMC regulatory operations.
• Other duties as assigned.

Skills

Attention to detail

Technical writing

Organizational skills

Communication skills

Time management

Education

Bachelor's degree in biochemistry, chemistry, biology or related pharmaceutical field

Tools

Regulatory document management systems

Job description

Pace Analytical Life Sciences is seeking a senior regulatory expert to lead CMC regulatory strategies for global programs. This role focuses on authoring and coordinating INDs, IMPDs, CTAs, amendments and annual reports to ensure compliance with FDA, EMA and ICH guidelines.

You will advise clients, manage multiple deliverables in a fast-paced environment and contribute to the development of efficient regulatory processes and templates for streamlined submissions.