Director, RA, OSD/API

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🔥 0 minutes ago

🏈 Ohio – Remote

🏈 Ohio – Remote

💵 $150k - $218k / year

⏰ Full Time

🔴 Lead

👔 Director

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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

• 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

• Accessibility/Disability Access • Professional development opportunities