Senior Regulatory Affairs Specialist PRN (Remote)

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

Job summary

Pace Analytical Life Sciences is seeking a senior Regulatory Affairs professional to lead and execute global CMC regulatory strategies for investigational, new, and marketed products, ensuring compliance with FDA, EMA, and other authorities.

The role involves authoring and compiling CMC sections, drafting module summaries, supporting regulatory interactions, and developing compliant processes to enable clinical trials and product approvals. Compensation is $85 per hour for 20-40 hours per month.

Qualifications

• 10+ years of experience in CMC/regulatory affairs.
• Authoring and compiling CMC sections of INDs, IMPDs, CTAs, amendments, and related filings.
• Knowledge of FDA, EMA, ICH guidelines.
• Excellent attention to detail and communication skills.

Responsibilities

• Author and compile CMC sections of regulatory applications.
• Draft CMC documents like Module 2 and 3 summaries, stability reports.
• Prepare responses to FDA/EMA/PMDA questions.
• Lead regulatory interactions for CMC strategies to support clinical trial initiation.
• Develop templates and workflows for compliant CMC operations.
• Other duties as assigned.

Skills

CMC regulatory affairs

Regulatory submissions

Technical writing

Project management

Global regulatory knowledge

Education

B.A./M.S./Ph.D. in biochemistry/chemistry/biology

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.