Regulatory Operations Manager

Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Summary of Role

The Regulatory Operations Manager supervises and executes electronic submission activities that support Lantheus drug product applications, drug listings, establishment registrations, and safety reports. They are responsible for submission scheduling and deliverables and ensuring deadlines are met. This role also serves as a training and knowledge resource for Regulatory submissions and Veeva RIM system. Propose process improvements and efficiencies.

Essential Functions

• Support new Veeva Registrations, Submissions, and Submissions Archive RIM system. Manage daily operation of the system and serve as a training resource for Regulatory users. Maintain and update RIM system SOPs, Work Instructions and job aids.
• Provide operational oversight, scheduling, and execution of Regulatory eCTD submissions, post-market SAE reporting, and FDA drug listing, establishment registration, and drug distribution reporting. Ensure submissions are compliant with regulations and guidance.
• Independently lead and execute routine and complex Regulatory eCTD submissions for US, Canada, and Europe. Provide advice on content and structure of submissions, setup meetings, create timelines, format and publish files, and manage participants and deadlines.
• Manage content compilation and submission of US FDA annual and aggregate safety reports. Ensure report quality and adherence to regulations, guidance, and agency deadlines.
• Supervise and train Regulatory Operations associates in the execution of their electronic submission assignments, technology usage, and new regulatory requirements.
• Develop, implement, and maintain regulatory standards and best practices for dossier management, publishing, and archiving and provide training to submission contributors.
• Select and maintain Regulatory Operations software, hardware, electronic gateways, CTD templates and submission technology and serve as a resource for technology usage and training.
• Serve as interface between Regulatory Operations and our external vendors and internal IT partners.

Minimum Skills, Experience and Education

• Bachelor's degree or equivalent with 5+ years' experience in a pharmaceutical Regulatory Operations environment with emphasis on eCTD dossier management.
• Experience with Veeva Registrations, Submissions, and Submissions Archive application.
• Experience with Starting Point CTD templates, Share Point, and ISI Toolbox preferred.
• Understanding of SPL and XML in relationship to FDA drug listings, establishment registrations, and SAE reporting.
• Advanced user of MS Word, Excel, PowerPoint, and Adobe Acrobat.

Other Requirements

• Ability to prioritize and work under pressure in a fast-paced environment to meet submission and project deadlines.
• Strong project management, leadership, and interpersonal skills.
• Excellent written and verbal communication skills.
• Demonstrated ability to manage, motivate, and develop staff.
• Self-starter with proven problem-solving and organizational skills

Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.

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