Principal Regulatory Affairs Specialist, Pharmaceutical Products (Hybrid)
Apply NowCompany: Stryker Corporation
Location: Princeton, NJ 08540
Description:
Work Flexibility: Hybrid
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.
Who we want
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.
What you need
Preferred
Travel Percentage: 10%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
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.
Who we want
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.
- Regulatory Strategy Development
- 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.
- Submission Management
- 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.
- Cross-Functional Collaboration
- 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.
- Compliance & Risk Management
- 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.
- Leadership & Mentorship
- 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 you need
- 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.
Preferred
- PhD, PharmD, or Master's
- RAC certification
- Masters in Regulatory Affairs
Travel Percentage: 10%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.