Senior Global Regulatory Affairs Lead, CMC Focus

LNN Pace Analytical Life Sciences, LLC; Washington; Hybrid; USD 99,000 - 132,000; Full time

Benefits offered by this job

Competitive salary

401K retirement savings plan

Tuition reimbursement

Job summary

Pace Analytical Life Sciences, LLC is seeking a Senior Regulatory Affairs professional to lead and execute global regulatory strategies for CMC in INDs, IMPDs, CTAs and post-market filings. You will author and assemble CMC sections, maintain documents, and interact with FDA, EMA, PMDA, and other authorities.

This full-time role offers a competitive benefits package and growth in a fast-paced, compliance-driven environment.

Qualifications

• B.A. / B.A./ M.S. / Ph.D. in biochemistry, chemistry, biology, or related pharmaceutical field with 10+ years of experience in CMC/regulatory affairs.

Responsibilities

• Regulatory Submissions: Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports.

Skills

Regulatory writing

Project coordination

Communication skills

Attention to detail

Education

Bachelor's or advanced degree in biochemistry/chemistry/biology

Tools

Regulatory document management systems

Job description

Pace Analytical Life Sciences, LLC is seeking a Senior Regulatory Affairs professional to lead and execute global regulatory strategies for CMC in INDs, IMPDs, CTAs and post-market filings. You will author and assemble CMC sections, maintain documents, and interact with FDA, EMA, PMDA, and other authorities.

This full-time role offers a competitive benefits package and growth in a fast-paced, compliance-driven environment.