Senior Regulatory Affairs Specialist PRN (Remote)

Pace Analytical Services, LLC; Maryland; Remote; USD 97,000 - 138,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401K retirement plan with employer-mas

Paid time off

Job summary

Pace Analytical Services, LLC is seeking a senior CMC regulatory professional to lead and execute global regulatory strategies for investigational, new and marketed products. You will prepare regulatory submissions, author CMC sections, and manage responses to authorities across FDA, EMA and other global bodies.

The ideal candidate has 10+ years in CMC/regulatory affairs, strong technical writing skills, and experience with regulatory document management systems in a fast-paced environment.

Qualifications

• Requires a degree in biochemistry, chemistry, biology or related field with 10+ years in CMC/regulatory affairs.
• Hands-on experience authoring and compiling CMC sections for INDs, IMPDs, CTAs and amendments.
• Strong knowledge of FDA, EMA and ICH regulatory guidelines.
• Excellent attention to detail, writing, organization, and communication skills.
• Ability to manage multiple deliverables and timelines in fast-paced environments.
• Experience with regulatory document management systems is preferred.

Responsibilities

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

Skills

CMC regulatory

Regulatory submissions

Technical writing

Project management

Education

Biochemistry/Chemistry/Biology degree

Tools

Regulatory document management systems

Job description

Shift:

Monday through Friday, 8:00AM - 5:00PM Approximately 20 - 40 hours per month

Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives.

Lead and execute global regulatory strategies to ensure our client's investigational, new, and marketed products are developed and maintained in compliance with global regulatory requirements. Serve as a strategic advisor to clients, ensuring regulatory compliance, influencing key stakeholders, and optimizing business outcomes.

Compensation: $85.00 per hour

Key Responsibilities:

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

• Documentation: Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols.

• Communication: Support regulatory interactions by preparing responses to CMC-related questions from FDA, EMA, PMDA, and other global health authorities.

• Strategy Implementation: Prepare and Lead Regulatory interactions for CMC regulatory strategies to support clinical trial initiation and advancement.

• Process Development: Contribute to the development of templates, processes, and workflows to support efficient and compliant CMC regulatory operations.

• Other duties as assigned.

Ideal Candidate:

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

• Hands-on experience authoring and compiling CMC sections of INDs, IMPDs, CTAs, amendments, and related filings.

• Strong knowledge of global CMC clinical regulatory requirements and guidelines, including FDA, EMA, and ICH.

• 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.

Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work.

Benefits

When you join Pace, you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft.

Equal Opportunity Employer

Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.