Director, Regulatory Affairs - Pharmaceuticals
Stryker
full-time
Posted on:
Location Type: Hybrid
Location: California • Illinois • United States
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Salary
💰 $167,000 - $362,100 per year
Job Level
About the role
- 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.
- Responsible for drug development including global regulatory strategy, submissions, approvals, and regulatory and quality compliance.
- Creates long term regulatory strategy for drug products.
- Manages a regulatory affairs team responsible for the division’s pharmaceutical products.
- Accountable for the regulatory strategy, requirements, deliverables, and results to support drug development both domestically and internationally.
- Provides regulatory guidance to and interacts with Marketing, Clinical, Legal, Operations, Compliance and R&D leadership.
- Leads communication with FDA and other regulatory agencies to gain alignment on most efficient regulatory pathways and gain product approvals.
Requirements
- Bachelor’s degree (B.S. or B.A.) in Engineering, Science, or related
- RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred
- 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.
Benefits
- salary plus bonus eligible
- generally eligible for short-term and long-term financial incentives
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategydrug developmentsubmissionsapprovalsregulatory compliancequality complianceNDADINAsIDEs510(k)
Soft skills
leadershippeople managementcommunicationinterpersonal skillsstrategic thinkingcollaboration
Certifications
RAC certificationMasters in Regulatory Affairs