Senior Global Regulatory Affairs Lead

Pace® Analytical Services; Massachusetts; On-site; USD 135,000 - 165,000; Full time

Benefits offered by this job

Medical benefits

Dental insurance

401K retirement plan

Job summary

Pace® Analytical Services is seeking an experienced Regulatory Affairs leader for global CMC compliance. The role focuses on authoring and leading regulatory submissions, ensuring alignment with FDA, EMA, and ICH guidelines, and advising clients on strategy and timelines.

The ideal candidate brings 10+ years in CMC/regulatory affairs, strong technical writing, and the ability to drive multiple deliverables in a fast-paced environment.

Qualifications

• Minimum 10+ years in CMC/regulatory affairs.
• Experience authoring CMC sections for INDs/IMPDs/CTAs.
• Knowledge of FDA, EMA, ICH guidelines.
• Excellent writing and communication skills.
• Ability to manage multiple deliverables in a fast-paced environment.

Responsibilities

• Author and compile CMC sections of regulatory applications (INDs, IMPDs, CTAs, amendments, and annual reports).
• Draft and maintain CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols.
• Support regulatory interactions by responding to CMC-related questions from FDA, EMA, PMDA and others.
• Lead and prepare regulatory interactions for CMC strategies to support clinical trial initiation and advancement.
• Contribute to templates, processes, and workflows to improve regulatory operations.

Skills

Regulatory strategy

CMC regulatory affairs

Technical writing

Project management

Communication skills

Education

Bachelor/Master/PhD in biochemistry/chemistry/biology

Tools

Regulatory document management systems

Job description

Pace® Analytical Services is seeking an experienced Regulatory Affairs leader for global CMC compliance. The role focuses on authoring and leading regulatory submissions, ensuring alignment with FDA, EMA, and ICH guidelines, and advising clients on strategy and timelines.

The ideal candidate brings 10+ years in CMC/regulatory affairs, strong technical writing, and the ability to drive multiple deliverables in a fast-paced environment.