Senior Director Global Regulatory Affairs
4 weeks ago
At Danaher Corporation, we are committed to accelerating the real-life impact of tomorrow's science and technology. As a key member of our team, you will play a critical role in shaping the future of medicine by advancing science in meaningful ways.
Job Summary
We are seeking a highly experienced and skilled Senior Director Global Regulatory Affairs to lead our Regulatory Affairs department. The successful candidate will be responsible for developing and executing regulatory strategies for drug development and commercialization, ensuring compliance with global regulations and standards across multiple markets.
Key Responsibilities
- Develop and execute regulatory strategies for drug development and commercialization
- Ensure compliance with global regulations and standards across multiple markets
- Lead regulatory submissions, including pre-market applications, product registrations, post-approval updates
- Monitor and interpret global regulatory requirements and trends
- Provide strategic guidance to internal stakeholders to mitigate risks and capitalize on opportunities
- Oversee regulatory submission activities, including authoring, review, and support of client filings
- Primary liaison for communications with FDA and other regulatory authorities
- Provide regulatory expertise and guidance to internal teams
- Lead and manage a team of regulatory professionals
Requirements
- Bachelor's degree in a relevant scientific discipline
- At least 12+ years of relevant experience in a QRA position supporting drug product commercialization
- Experience leading regulatory submissions and interactions with regulatory authorities in different countries
- Strong leadership and management skills
- Excellent analytical, problem-solving, and decision-making abilities
What We Offer
We offer a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees. Additionally, we provide opportunities for professional growth and development, as well as a collaborative and dynamic work environment.
About Us
Danaher Corporation is a global leader in the life sciences, diagnostics, biotechnology, and other industries. We partner with customers across the globe to help them solve their most complex challenges and accelerate the real-life impact of tomorrow's science and technology.
Equal Opportunity Employer
We are an equal opportunity employer and welcome applications from diverse candidates. We are committed to creating an inclusive and diverse work environment that values and respects the contributions of all employees.
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