Director, RA, OSD/API

Thermo Fisher Scientific

Director of Regulatory Affairs leading compliance initiatives and strategic growth at Thermo Fisher Scientific. Overseeing global regulatory activities and shaping strategies for product development.

Posted 7/25/2026full-timeRemote • Ohio • 🇺🇸 United StatesLead💰 $150,000 - $218,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory compliance and strategy development within the pharmaceutical and medical device sectors, with a strong focus on global regulatory requirements and successful product submissions. Proven leadership in managing multi-site teams and influencing regulatory policy while driving business growth.

Highest-signal resume keywords

Regulatory ComplianceRegulatory Strategy DevelopmentLeadership ExperienceProject ManagementFluency in English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsQuality Management SystemsGlobal Regulatory RequirementsFDA GuidelinesEMA GuidelinesICH GuidelinesRegulatory AffairsManufacturing OperationsBusiness AcumenStrategic Thinking

Soft Skills

Excellent CommunicationNegotiation SkillsInfluencing SkillsOrganizational SkillsAbility to Work in Matrix Organization

Tools & Technologies

Regulatory SystemsStandard Office Technology

Industry Keywords

PharmaceuticalMedical DeviceCDMOTOPRAPDALife SciencesPharmacyChemistryMicrobiologyProfessional Associations

About the role

Key responsibilities & impact

Lead strategic initiatives to ensure regulatory compliance while driving business growth across multiple regions
Develop and implement regulatory strategies
Mentor teams and manage relationships with regulatory agencies worldwide
Oversee regulatory compliance activities and provide expert guidance
Ensure successful product submissions across various jurisdictions
Collaborate with cross-functional teams to shape regulatory strategy for product development, manufacturing, and commercialization
Influence global regulatory policy and drive innovation in regulatory approaches

Requirements

What you’ll need

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

Comp & perks

Accessibility/Disability Access
Professional development opportunities