Regulatory Operations Manager

4 weeks ago

Bedford, United States Lantheus Medical Imaging Inc Full time
Job DescriptionJob Description

Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, 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
  • This position is site-based and requires a presence on-site of 3 days per week in Bedford, MA when not travelling.

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.

#LI-HYBRID

  • Manager, Regulatory Affairs, Labeling

    3 months ago

    Bedford, United States Lantheus Full time

    Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, 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...

  • Manager, Regulatory Affairs, Labeling

    3 months ago

    Bedford, United States Lantheus Medical Imaging Inc Full time

    Job DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, 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...

  • Regulatory Affairs Manager

    1 week ago

    New Bedford, Massachusetts, United States Lantheus Medical Imaging Inc Full time

    Position OverviewLantheus Medical Imaging Inc., a leader in the medical imaging field, is seeking a skilled professional to oversee the development and management of global product labeling components. With a legacy of over 60 years, we are committed to enhancing patient care through innovative diagnostics and therapeutics.Role SummaryThe successful...

  • Contract Regional Accounts Receivable Manager

    5 days ago

    Bedford, Texas, United States SLP Operations, LLC Full time

    Job Summary:SLP Operations, LLC is seeking an experienced Interim Regional Accounts Receivable Manager to provide training, guidance, and support on policies, processes, and best practices for Business Office operations and activities.Key Responsibilities:Provide oversight and support for the full scope of center-based Business Office operations and...

  • Regulatory Compliance Manager I

    2 weeks ago

    Bedford, Massachusetts, United States Werfen Full time

    Overview:As a Regulatory Compliance Manager I at Werfen, you will play a pivotal role in overseeing the pre-market regulatory activities essential for ensuring adherence to various global standards, including US FDA, Health Canada, and European regulations for in vitro diagnostic devices.Key Responsibilities:Pre-Market Activities:Engage with design teams to...

  • Regulatory Affairs Manager

    2 weeks ago

    New Bedford, Massachusetts, United States Lantheus Medical Imaging Inc Full time

    Position OverviewLantheus Medical Imaging Inc. is a pioneering organization in the medical imaging sector, dedicated to enhancing patient care through innovative diagnostics and therapeutic solutions. With a commitment to excellence, we strive to create a dynamic workplace that values diverse perspectives and fosters collaboration.Role SummaryThe selected...

  • Regulatory Affairs Manager

    1 week ago

    New Bedford, Massachusetts, United States Lantheus Medical Imaging Inc Full time

    Position OverviewLantheus Medical Imaging Inc., a leader in the medical imaging sector, is dedicated to advancing patient care through innovative diagnostics and therapeutic solutions. With a legacy of over 60 years, we are committed to fostering a collaborative and inclusive workplace where every team member plays a crucial role in our success.Role...

  • Associate Director, Regulatory Affairs, CMC

    1 month ago

    Bedford, United States Lantheus Medical Imaging Inc Full time

    Job DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, 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...

  • Interim Regional Accounts Receivable Manager

    1 month ago

    Bedford, United States SLP Operations, LLC Full time

    Job DescriptionJob DescriptionDescription:Currently seeking an Interim/Contract Regional Accounts Receivable Manager for 6-8 weeks.If you are looking for a great opportunity with an exceptional LTC Company then look no further.At SLP Operations, LLC., our commitment is to provide love, attention and optimal care one resident at a time. We realize...

  • Clinical Operations Nurse

    4 days ago

    Bedford, Texas, United States SLP Operations, LLC Full time

    SLP OPERATIONS, LLCPosition: Clinical Operations NurseWe are seeking a dedicated Clinical Operations Nurse with a minimum of 3-5 years of experience in a Director of Nursing (DON) role. This is an exceptional opportunity for a professional who possesses strong communication skills, staff development expertise, and a focus on quality management. We offer...

  • Clinical Operations Manager

    1 week ago

    Bedford, Massachusetts, United States Pramand LLC Full time

    Job OverviewSalary: CompetitiveAbout Pramand LLC:Pramand LLC is a pioneering company specializing in the development of innovative medical devices utilizing proprietary hydrogel materials. Our mission is to enhance patient outcomes while reducing therapy costs. We have successfully created a hydrogel implant aimed at minimizing intrauterine adhesions and...

  • Aviation Operations Manager

    2 weeks ago

    Bedford, Massachusetts, United States BBA Aviation Plc. Full time

    Job Description BBA Aviation Plc. is a leading global provider of aviation services, operating numerous locations and employing thousands of professionals worldwide. Our team members benefit from a comprehensive range of perks, including health and wellness programs, competitive retirement plans, paid leave, educational support, and extensive opportunities...

  • Research Operations

    3 months ago

    Bedford, United States Lantheus Medical Imaging Inc Full time

    Job DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, 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...

  • Research Operations

    3 weeks ago

    Bedford, United States Lantheus Full time

    Description Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, 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...

  • Research Operations

    2 months ago

    Bedford, United States Lantheus Full time

    Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, 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...

  • Research Operations

    2 weeks ago

    Bedford, United States Lantheus Full time

    Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, 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...

  • Packaging Operations Manager

    4 hours ago

    Bedford, Massachusetts, United States Anika Full time

    Job SummaryAnika is seeking a highly skilled Packaging Supervisor to oversee the scheduling, execution, and completion of activities in our ISO 13485 packaging environment. The successful candidate will ensure safety, quality, compliance, delivery, and cost are maintained on the packaging floor.Key ResponsibilitiesSupervise Work Activities: Ensure compliance...

  • Regional Maintenance Manager

    4 days ago

    Bedford, Texas, United States SLP Operations, LLC Full time

    **Job Summary**We are seeking a highly skilled and experienced Regional Maintenance Supervisor to join our team at SLP Operations, LLC. As a key member of our operations team, you will be responsible for ensuring the maintenance and upkeep of our facilities in the West Texas Region.**Key Responsibilities:**Under the direct supervision of the Vice President...

  • Area Operations Manager

    2 weeks ago

    New Bedford, Massachusetts, United States United Apartment Group Full time

    Position OverviewUnited Apartment Group is in search of a seasoned Area Operations Manager to lead our residential communities. The successful candidate will be responsible for the comprehensive management of daily property operations, ensuring the enhancement and value retention of the properties within their designated area.Key Responsibilities:Offer...

  • VP, Quality Operations

    1 month ago

    Bedford, United States Obsidian Therapeutics Full time

    VP, Quality Operations Bedford, MA About Us… Obsidian Therapeutics is expanding the reach of TIL therapy.  We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. Obsidian’s programs apply our cytoDRiVE® platform technology to express regulated...