Regulatory Operations Associate Jobs in Cambridge, MA

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.

This position is on-site and requires a presence of 3 days per week on-site in Bedford, MA.

Summary of role

Primary responsibilities include execution of electronic submission activities that support our marketing applications, drug listings, establishment registrations, and safety reports. Serve as a training and troubleshooting resource for Regulatory electronic systems and applications. Propose process improvements and efficiencies.

Key Responsibilities/Essential Functions

• Independently lead and execute routine and complex Regulatory eCTD submissions for US, Canada, and Europe. Responsibilities include providing advice on content and structure of submissions, attending meetings, creating timelines, providing templates, formatting and publishing documents, managing participants and deadlines.
• Manage content compilation and submission of US FDA annual and aggregate reports. Ensure report quality, adherence to regulations, guidance, and agency deadlines.
• Submit Individual Case Safety Reports (ICSRs) to FDA FAERS and ensure compliance with changing regulations.
• Create and submit valid SPL formatted drug listings and registrations to FDA. Serve as an SPL technical resource.
• Create and update Regulatory Operations process Checklists, User Guides, SOPs and Work Instructions.
• Maintain Regulatory Operations software, hardware, electronic gateways, templates and submission technology and serve as a resource for technology usage and training.
• Schedule, monitor, and track Regulatory submissions to ensure corporate and health authority deadlines are met.
• Identify, evaluate, and implement new submission processes as mandated by regulations.
• Setup, utilize, and troubleshoot electronic submission gateways.
• Recommend cost, quality and/or efficiency changes to Regulatory submission processes based on best practices, regulations, and guidance.
• Manage and archive submissions and correspondence in the Veeva Submissions and Submissions Archive RIM System.

Basic Qualifications

Bachelor's degree or equivalent with a minimum of 3 years of experience in pharmaceutical Regulatory Operations demonstrating the following skills:

• Experience managing, publishing, and transmitting eCTD submissions to health authorities with knowledge of US, EU, and Canada regional requirements.
• Advanced user of Microsoft Office products, Adobe Acrobat, ISI Toolbox, and Starting Point CTD templates.
• Understanding of SPL and FDA listing and registration processes.
• Experience with Veeva Registrations, Submissions, and Submissions Archive application.

Other Requirements

• Must be extremely organized and detail oriented.
• Demonstrated technical and problem solving skills.
• Able to work under pressure to meet deadlines and adjust to changes in priorities.
• Able to work independently or as part of a team as required by circumstances.
• Desire and ability to learn new processes and skills to keep up with rapidly changing regulatory and submission requirements.
• Excellent project management skills including management of project participants.
• Excellent written and verbal communication skills.

Core Values

• Let people be their best
• Respect one another and act as one
• Learn, adapt, and win
• Know someone's health is in our hands
• Own the solution and make it happen

Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by 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.

Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.