Thermo Fisher Scientific

Director RA OSD/API

Thermo Fisher Scientific$150K — $218K *
US-AnywhereRemote in Cincinnati, OH
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Advanced Degree plus 6 years or Bachelor's Degree plus 8 years in regulatory affairs
  • Comprehensive knowledge of global regulatory requirements (FDA, EMA, ICH)
  • Successful record of regulatory submissions and agency interactions
  • Experience managing and mentoring multi-site teams
  • Proven expertise in regulatory strategy development
  • Advanced project management and organizational skills
  • Fluency in English, additional language skills advantageous
  • Ability to travel internationally 25-50% of the time

Responsibilities

  • Lead strategic initiatives for regulatory compliance and business growth
  • Develop and implement regulatory strategies across multiple regions
  • Mentor regulatory affairs teams and shape their professional growth
  • Oversee regulatory compliance activities and product submissions
  • Provide expert guidance on regulatory requirements and compliance
  • Collaborate with cross-functional teams to influence product strategy
  • Drive innovation in regulatory approaches and influence global policy

Benefits

  • Opportunity to impact global healthcare
  • Leadership role with significant responsibility
  • Mentorship opportunities within the Regulatory Affairs team
  • Exposure to international regulatory environments
  • Possibility of shaping regulatory policy and compliance strategies
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

DESCRIPTION:
Join our Regulatory Affairs team at Thermo Fisher Scientific, where you'll make a significant impact on global healthcare through innovative solutions. As Director of Regulatory Affairs, you'll lead strategic initiatives to ensure regulatory compliance while driving business growth across multiple regions. This key leadership role involves developing and implementing regulatory strategies, mentoring teams, and managing critical relationships with regulatory agencies worldwide.

You'll oversee regulatory compliance activities, provide expert guidance on regulatory requirements, and ensure successful product submissions across various jurisdictions. Working closely with cross-functional teams, you'll shape regulatory strategy for product development, manufacturing, and commercialization while maintaining the highest standards of compliance. This role offers the opportunity to influence global regulatory policy and drive innovation in our 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)

Compensation
The salary range estimated for this position based in Ohio is $150,000.00-$218,000.00.

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ

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