Senior Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Illinois, +5 more states.

📋 Description

• Oversee and implement global regulatory strategies for investigational, new, and marketed products.

• Provide guidance to clients regarding regulatory compliance, stakeholder engagement, and business outcomes.

• Author and assemble CMC sections for INDs, IMPDs, CTAs, amendments, and annual reports.

• Draft and update Module 2 and 3 summaries, stability reports, and comparability protocols.

• Prepare responses to CMC-related inquiries from FDA, EMA, PMDA, and other international health authorities.

• Prepare for and facilitate regulatory interactions that support the initiation and progression of clinical trials.

• Create templates, processes, and workflows for efficient and compliant CMC regulatory operations.

• Execute additional responsibilities as assigned.

⛳️ Requirements

• B.A., M.S., or Ph.D. in biochemistry, chemistry, biology, or a related pharmaceutical discipline.

• A minimum of 10+ years of experience in CMC/regulatory affairs.

• Direct experience in authoring and compiling CMC sections for INDs, IMPDs, CTAs, amendments, and associated filings.

• In-depth knowledge of global CMC clinical regulatory requirements and guidelines, including those from FDA, EMA, and ICH.

• Exceptional attention to detail, along with strong technical writing, organizational, and communication skills.

• Capability to manage multiple deliverables and timelines in a fast-paced environment.

• Familiarity with regulatory document management systems.

🏝️ Benefits

• Medical, dental, and vision benefits.

• 401K retirement savings plan with 100% immediate vesting in the employer match.

• Life insurance.

• Disability benefits.

• Voluntary benefits.

• Paid time off for holidays, sick days, and vacation.

• Health Savings Account (HSA).

• Wellness program.

• Flexible spending accounts.

• Tuition reimbursement.

• Employee Assistance program.

• Parental leave.

• Optional legal coverage.

• Identity theft protection.