Global Regulatory Affairs Leader, CMC Strategy

Pace® Analytical Services; North Carolina; On-site; USD 150,000 - 200,000; Full time

Benefits offered by this job

Medical, dental, vision

401K retirement plan

Paid time off

Tuition reimbursement

Employee Assistance program

Parental leave

ID theft protection

Job summary

Pace® Analytical Services is seeking a senior professional to lead regulatory strategies and CMC submissions for investigational, new, and marketed products. You will ensure global compliance, influence stakeholders, and optimize regulatory outcomes.

Candidates should have 10+ years in CMC/regulatory affairs, hands-on experience with INDs, IMPDs, CTAs, and related filings, and deep knowledge of FDA/EMA/ICH guidelines. Strong writing and project management skills are essential.

Qualifications

• 10+ years in CMC/regulatory affairs with global scope.
• Experience authoring and compiling CMC sections for INDs/CTAs/IMPDs.
• Strong knowledge of FDA/EMA/ICH guidelines and regulatory processes.

Responsibilities

• Author and compile CMC sections for global regulatory submissions.
• Draft high-quality regulatory documents (Module 2/3 summaries, stability reports).
• Prepare responses to regulatory questions from agencies like FDA/EMA/PMDA.
• Lead and support regulatory interactions for clinical trial initiation.
• Develop templates and workflows for compliant CMC operations.

Skills

Regulatory strategy

CMC regulatory affairs

Regulatory submissions

Technical writing

Regulatory document management

Cross-functional collaboration

Education

Bachelor's degree in biochemistry/chemistry/biology or related field

Advanced degree (MS/PhD) preferred

Tools

Regulatory document mgmt systems

Job description

Pace® Analytical Services is seeking a senior professional to lead regulatory strategies and CMC submissions for investigational, new, and marketed products. You will ensure global compliance, influence stakeholders, and optimize regulatory outcomes.

Candidates should have 10+ years in CMC/regulatory affairs, hands-on experience with INDs, IMPDs, CTAs, and related filings, and deep knowledge of FDA/EMA/ICH guidelines. Strong writing and project management skills are essential.