Director, Regulatory Affairs - Pharmaceuticals

Lensa is a career site that helps job seekers find great jobs in the US. We are not a staffing firm or agency. Lensa does not hire directly for these jobs, but promotes jobs on LinkedIn on behalf of its direct clients, recruitment ad agencies, and marketing partners. Lensa partners with DirectEmployers to promote this job for Stryker. Clicking "Apply Now" or "Read more" on Lensa redirects you to the job board/employer site. Any information collected there is subject to their terms and privacy notice.

Position Summary

The Director, Regulatory Affairs - Pharmaceuticals provides leadership, people management, and technical expertise for the regulatory affairs team supporting the business unit's drug product. Interacts with the business unit's cross-functional leadership team to support the direction, strategy, and growth of the organization, specifically related to the business unit's drug and combination product(s). Responsible for drug development including global regulatory strategy, submissions, approvals, and regulatory and quality compliance.

Essential Duties And Responsibilities

• Serves as member of the extended business unit leadership team.Able to effectively communicate, interact, and navigate issues at leadership level.
• Creates long term regulatory strategy for drug products, provides input on combination products, and identifies team needs by understanding the industry and regulatory landscape in combination with the business priorities and goals.
• Manages a regulatory affairs team responsible for the division's pharmaceutical products.Hires, trains, develops, coaches/ mentors and motivates staff. Conducts performance management.
• Accountable for the regulatory strategy, requirements, deliverables, and results to support drug development both domestically and internationally.Regulatory pathways may include INDs, NDA or sNDA, DINAs, etc.
• Provides regulatory guidance to and interacts with Marketing, Clinical, Legal, Operations, Compliance and R&D leadership.
• Leads team in development and implement pharmaceutical quality system and process requirements for business in order to ensure compliance to external regulations and standards.Responsible for commercial drug product disposition and release in addition to Quality Assurance responsibilities.Viewed as pharmaceutical regulatory expert within business.
• Leads communication with FDA and other regulatory agencies to gain alignment on most efficient regulatory pathways and gain product approvals.Represents pharmaceutical aspects in external agency audits/inspections.
• Stays abreast of external pharmaceutical regulatory requirements and expectations.
  
  

Education & Special Trainings

• Bachelor's degree (B.S. or B.A.) in Engineering, Science, or related
• RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred
  
  

Qualifications & Experience

• Minimum 15 years of experience, including 10 years in an FDA regulated industry
• 5 years of managerial experience preferred
• Experience with successful NDA and DINAs. Prefer additional experience with IDEs/ 510(k)s and/or combination products.
  
  

Physical & Mental Requirements

• Travel approximately 25%
• Manage complex technical questions and navigate through uncertainty
• Mental drive to operate at high level for long project duration
• Ability to analyze complex data
• Ability to analyze and understand regulatory requirements and standards
• Ability to communicate and present to various stakeholders, both internally and externally
• Strong organizational skills
• Self-initiated
• Demonstrated ability to lead complex cross functional teams and projects
  
  

$167,000 - $362,100 salary plus bonus eligible generally eligible for short-term and long-term financial incentives benefits.? Individual pay is based on skills, experience, and other relevant factors.

Posted Date: 01/13/2026

This role will be posted for a minimum of 3 days.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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.

If you have questions about this posting, please contact support@lensa.com