Director, RA OSD/API
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Ohio • United States
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Salary
💰 $150,000 - $218,000 per year
Job Level
About the role
- Lead strategic initiatives to ensure regulatory compliance while driving business growth
- Develop and implement regulatory strategies, mentor teams, and manage critical relationships with regulatory agencies worldwide
- Oversee regulatory compliance activities and provide expert guidance on regulatory requirements
- Ensure successful product submissions across various jurisdictions
- Shape regulatory strategy for product development, manufacturing, and commercialization while maintaining high standards of compliance
- Influence global regulatory policy and drive innovation in regulatory approaches
Requirements
- Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in pharmaceutical/medical device regulatory affairs with emphasis on manufacturing operations
- Preferred Fields of Study: Life Sciences, Pharmacy, Chemistry, Microbiology, or related field
- Comprehensive knowledge of global regulatory requirements, particularly FDA, EMA, and ICH guidelines
- Successful track record of regulatory submissions and agency interactions
- Leadership experience managing and mentoring multi-site teams
- Experience in regulatory strategy development and implementation
- Demonstrated expertise in regulatory compliance and quality management systems
- Advanced project management and organizational skills
- Excellent verbal and written communication abilities
- Effective negotiation and influencing skills
- Ability to work effectively in a matrix organization
- Business acumen and strategic thinking capabilities
- Proficiency in standard office technology and regulatory systems
- Fluency in English required; additional language skills advantageous
- Ability to travel 25-50% of time, primarily international
- Experience with CDMO/pharmaceutical services preferred
- Knowledge of current industry trends and participation in professional associations (e.g., TOPRA, PDA)
Benefits
- Reasonable accommodation for individuals with disabilities
- Opportunity for professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory complianceregulatory strategy developmentregulatory submissionsquality management systemsproject managementglobal regulatory requirementsFDA guidelinesEMA guidelinesICH guidelinespharmaceutical services
Soft Skills
leadershipmentoringcommunicationnegotiationinfluencingorganizational skillsstrategic thinkingbusiness acumenteam managementmatrix organization collaboration