Senior Regulatory Affairs Specialist

🔥 0 minutes ago

🌽 Illinois, North Carolina, +4 more states – Remote

🌽 Illinois – Remote 🌲 North Carolina – Remote 🏈 Ohio – Remote 🦀 Maryland – Remote 🍂 Massachusetts – Remote ❄️ Minnesota – Remote

💵 $85 / hour

⏱ Part Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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Pace® Labs

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Pace® Labs is a nationwide network of laboratories and professional services that provides analytical and environmental testing, life‑sciences CDMO/CRO and central laboratory services, building‑science and laboratory support, and emergency response for contamination and outbreak events. The company delivers environmental sampling and testing (air, water, soil, PFAS, Legionella, VOCs, metals, radiochemistry, etc. ), GMP analytical testing and formulation/clinical manufacturing support for pharma and biopharma, medical device testing and regulatory/compliance consulting, plus instrument, cleanroom and facility services to regulated industries.

📋 Description

• Lead and execute global regulatory strategies for investigational, new, and marketed products • Advise clients on regulatory compliance, stakeholder influence, and business outcomes • Author and compile CMC sections of INDs, IMPDs, CTAs, amendments, and annual reports • Draft and maintain Module 2 and 3 summaries, stability reports, and comparability protocols • Prepare responses to CMC-related questions from FDA, EMA, PMDA, and other global health authorities • Prepare and lead regulatory interactions supporting clinical trial initiation and advancement • Develop templates, processes, and workflows for efficient and compliant CMC regulatory operations • Perform other duties as assigned

🎯 Requirements

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

• 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 holiday, sick, and vacation days • HSA • Wellness program • Flexible spending accounts • Tuition reimbursement • Employee Assistance program • Parental leave • Optional legal coverage • ID theft protection