Senior Regulatory Support Manager
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danahers 15+ operating companies, our work saves livesand were all united by a shared commitment to innovate for tangible impact. Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement, you help turn ideas into impact innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System which makes everything possible. Were looking for a Senior Regulatory Support Manager to join Cytivas Customer Regulatory Support (CRS) team. As Regulatory Support Manager you are responsible for providing support to Product Managers, Regions and customers by providing quality documents and regulatory support in response to customers requests for quality, regulatory and technical-related information. As a member of the Customer Regulatory Support team, you will add value to bioprocess products and demonstrate a commitment to customer satisfaction. What youll do: - Maintain a high-level understanding of customer regulatory requirements applicable to the bioprocess business and its products.
- Develop, review, and maintain regulatory support documentation to ensure compliance in customer regulated environments.
- Conduct regulatory investigations and prepare, issue, and maintain statements, certificates, and related compliance documentation.
- Serve as the regulatory support subject matter expert, collaborating with R&D, Quality Assurance, Product Management, and cross-functional global project teams.
- Manage and respond to customer regulatory inquiries in a timely and effective manner, utilizing internal and external databases and ensuring complete and accurate documentation of all regulatory activities.
The essential requirements of the job include: - Bachelor of Science degree in Chemistry, Pharmacy or related field.
- 5-10 years of experience from relevant positions within Quality Assurance, Regulatory, or Product Management.
- Good understanding of GMP and knowledge of regulatory requirements in the bioprocess industry.
- Excellent communication skills and fluency in English, both written and spoken.
It would be a plus if you also have:
- Experience of working in large matrix organizations.
- Fluency in the language of the country of employment.
- Experience in customer communication.
The salary range for this role is $92,000-$110,000. This is the range that we in good faith believe isthe range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and RetirementBenefits to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, anddeterminable. The amount and availability of any bonus, commission, benefits, or any other form of compensation andbenefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid andmay be modified at the Companys sole discretion, consistent with the law. #LI-GC1 Join our winning team today. Together, well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@danaher.com.
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