Job Details

Senior Regulatory Affairs Specialist (Remote)

Shift: Monday through Friday, 8:00 AM - 5:00 PM (with some flexibility)

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 clients 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: $150,000.00 - 175,000.00 per year

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./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.

Benefits

When you join Pace, you commit to work that makes a positive impact on our communities and our world. Full?time roles are eligible for a comprehensive benefits program including competitive salaries, medical, dental, vision, 401(k) retirement savings plan, life, disability, paid time off, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance Program, parental leave, optional legal coverage, and identity theft protection.

Seniority level

Mid?Senior level

Employment type

Full?time

Job function

Legal

Industries

Executive Offices

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.

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