Principal Regulatory Affairs Specialist, Pharmaceutical Products (Hybrid)

Stryker • Trout Valley, IL

283d • Hybrid

About The Position

We are currently seeking a Principal Regulatory Affairs Specialist, (Pharmaceutical Products) to join our Medical Division. This is a Hybrid role based in Cary, Illinois. As the Principal Regulatory Affairs Specialist, you will play a pivotal role in shaping and executing global regulatory strategies for drug development and lifecycle management. This position requires extensive expertise in regulatory frameworks, strategic planning, and cross-functional collaboration to ensure timely regulatory approvals and compliance with international standards. The individual will act as a senior advisor to internal teams, providing regulatory guidance throughout all phases of drug development and commercialization.

Requirements

• Advanced degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• Minimum of 10 years of experience in drug regulatory affairs.
• Experience interacting with regulatory agencies.

Nice To Haves

• Preferred PhD, PharmD, or Master's RAC certification.
• Masters in Regulatory Affairs.

Responsibilities

• Lead the development and implementation of comprehensive regulatory strategies for new drug applications (NDAs), OTC drug products, including those marketed under the FDA's OTC monograph system, investigational new drugs (INDs), and post-approval submissions across global markets.
• Monitor and interpret evolving regulatory guidelines, policies, and industry trends to proactively adapt strategies.
• Provide strategic input on clinical trial designs, product formulations, and labeling to align with regulatory requirements.
• Oversee the preparation, review, and submission of high-quality regulatory dossiers, including clinical trial applications (CTAs), INDs, NDAs, and variations.
• Ensure timely submission of documents in compliance with FDA, EMA, HC, ICH, and other international regulatory authorities.
• Manage responses to regulatory inquiries and negotiate directly with agencies to secure approvals.
• Serve as the primary regulatory representative on cross-functional project teams involving R&D, clinical development, quality assurance, manufacturing, and marketing.
• Provide expert guidance on regulatory requirements during product development phases and post-market activities.
• Collaborate with legal teams to ensure compliance with intellectual property laws and promotional regulations.
• Ensure adherence to current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and other applicable quality standards.
• Assess the impact of product or process changes on existing approvals and coordinate necessary regulatory actions.
• Support audits and inspections by regulatory bodies; lead remediation efforts as required.
• Mentor junior regulatory staff members by sharing expertise in regulatory science and strategic planning.
• Develop internal training programs on regulatory updates and best practices.
• Contribute to the creation or revision of internal standard operating procedures (SOPs) related to regulatory affairs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: Master's degree