Senior Regulatory Support Manager

Danaher•Marlborough, MA

About The Position

At Cytiva, one of Danaher’s 15+ operating companies, the Senior Regulatory Support Manager joins Cytiva’s Customer Regulatory Support (CRS) team. This role is 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, the manager will add value to bioprocess products and demonstrate a commitment to customer satisfaction. Cytiva focuses on providing new solutions to transform human health, supporting customers in life-saving activities from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

Requirements

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.

Nice To Haves

Experience of working in large matrix organizations.
Fluency in the language of the country of employment.
Experience in customer communication.

Responsibilities

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.