Senior Director, Regulatory Affairs

20 hours ago

Bedford MA 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 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


We are seeking an experienced leader with proven management and regulatory expertise related to advertising/promotional materials and labeling.


Key Responsibilities/Essential Functions

  1. Leads and manages a team of direct reports and may manage other people leaders. Hires, develops, and retains diverse top talent in the team. Sets clear and elevating goals for the team and individual direct reports. Coaches direct reports on their performance, development, and career interests.
  2. Collaborate with colleagues in Commercial, Medical Affairs, Legal, Compliance and other expertise areas in creation of promotional and disease awareness communications, field training materials, and materials and communications used in scientific exchange, for assigned product(s).
  3. Act as Lantheus liaison to the FDA's Office of Prescription Drug Promotion (OPDP) for assigned product(s), including preparing correspondence for advisory comment submissions and conducting negotiations.
  4. Monitor new or revised legislation, regulations, guidance documents, industry standards, and enforcement actions related to promotional communications, disease awareness, scientific exchange, and human subject protection, and analyze and communicate their relevance.
  5. Work closely with Regulatory Operations in making timely submissions of promotional materials to FDA.
  6. Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across therapeutic areas.
  7. Represents or otherwise oversees other team members representing RA Labeling on RA Project Teams, at cross-functional submission team meetings, and on joint labeling/safety meetings with partner companies.
  8. Oversees and guides or otherwise leads review/approval of U.S. labeling in Structured Product Labeling (SPL) format, artwork requests, archiving labeling documents, and updating label histories.
  9. Manages complex labeling negotiations with regulatory authorities.
  10. Trains other RA Labeling colleagues or cross-functional team members in various matters relating to RA labeling.

Basic Qualifications

  1. PharmD/PhD with 8+ years' relevant experience.
  2. MA/MS/MBA with 12+ years' relevant experience.
  3. BA/BS with 14+ years' relevant experience.
  4. 8+ years' experience in prescription drug labeling.
  5. Extensive experience leading development of regulatory labeling or related strategies as well as Ad/Promo strategy and leadership.
  6. Extensive experience in NDA/BLA labeling and labeling negotiations.
  7. Extensive experience participating in cross-functional projects and teams.
  8. Extensive leadership experience and proven effectiveness, whether through direct people leadership or matrix leadership.
  9. Proven track record of successfully managing large scale, complex, time-sensitive projects.
  10. Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.

Other Requirements

  1. Veeva knowledge and experience is a plus.
  2. Radiopharmaceutical experience is a plus.

Core Values:

The ideal candidate will embody Lantheus 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 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


#LI-HYBRID


#LI-HYB

#J-18808-Ljbffr

  • Senior Director of Regulatory Affairs Advertising

    2 days ago

    Boston, MA, United States EPM Scientific - Phaidon International Full time

    Title: Senior Director of Regulatory Affairs Ad/Promo Summary: A global biopharmaceutical company, dedicated to pursing novel therapeutics to aid those with chronic illnesses is looking to grow their Regulatory Affairs team and bring on a Senior Director of Regulatory Affairs Ad/Promo to join their team! The team is growing rapidly as they have had great...

  • Senior Director of Regulatory Affairs Advertising

    1 month ago

    Boston, MA, United States EPM Scientific Full time

    Title: Senior Director of Regulatory Affairs Ad/PromoSummary: A global biopharmaceutical company, dedicated to pursing novel therapeutics to aid those with chronic illnesses is looking to grow their Regulatory Affairs team and bring on a Senior Director of Regulatory Affairs Ad/Promo to join their team! The team is growing rapidly as they have had great...

  • Senior Regulatory Affairs Director, Global Regulatory Strategy

    20 hours ago

    Boston, MA, United States AstraZeneca Full time

    Do you have expertise in, and passion for, Regulatory Affairs? Would you like to apply your expertise and channel the scientific capabilities in a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we are using cell therapy to revolutionize the treatment of...

  • Regulatory Affairs Director

    2 days ago

    San Francisco, CA, United States Biolink360 Full time

    Company Location: Bay AreaComp: 150K-220KPosition Reports to: VP of Regulatory and Quality Director of Regulatory Affairs - San Francisco We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. This person will lead interactions with regulatory agencies globally and help develop...

  • Director of Pharmacovigilance

    2 days ago

    Boston, MA, United States Biolink360 Full time

    Director of Pharmacovigilance & Regulatory Affairs About the Company Our client is a market leader in diagnostic imaging agents, a global company with under 1000 employees, with HQ in Boston. The person hired will direct all global pharmacovigilance activities and safety reporting for all marketed products, and oversee internal work team activities, and...

  • Director of Regulatory Affairs

    4 weeks ago

    Weston, FL, United States Transpire Bio Full time

    Job Title: Director Regulatory AffairsLocation: Weston, FL (near Miami and Fort Lauderdale, Florida (FL))Function: Regulatory AffairsReports to: Chief Regulatory Affairs Officer Job Summary:The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA submission and oversee and manage all ANDA regulatory activities pre-...

  • Sr. Director, Global Regulatory Affairs

    1 month ago

    Boston, MA, United States AVEO Pharmaceuticals Full time

    JOB TITLE: Sr. Director, Global Regulatory Affairs REPORTS: Vice President, Regulatory Affairs DEPARTMENT: Regulatory Affairs DATE PREPARED: October 17, 2024 JOB SUMMARY: AVEO Oncology is seeking an experienced Senior Director, Regulatory Affairs who will develop and execute global regulatory strategies in support of the development for assigned...

  • Director of Regulatory Affairs

    4 weeks ago

    Boston, MA, United States Meet Full time

    Position OverviewOur client, an innovative biopharma company, seeks a Director of Regulatory Affairs to drive regulatory strategy for their anti-infective portfolio through all development phases. This role involves co-leading a US NDA with a cross-functional project team and serving as the FDA liaison. Working remotely from the US with international teams,...

  • Director of Regulatory Affairs

    4 weeks ago

    Boston, MA, United States Meet Full time

    Position OverviewOur client, an innovative biopharma company, seeks a Director of Regulatory Affairs to drive regulatory strategy for their anti-infective portfolio through all development phases. This role involves co-leading a US NDA with a cross-functional project team and serving as the FDA liaison. Working remotely from the US with international teams,...

  • Senior Director, Regulatory Affairs

    2 days ago

    Redwood City, CA, United States Adverum Biotechnologies Full time

    The Talent Acquisition / HR team manages the recruiting for all positions at Adverum. We only accept resumes from search agencies or recruiters if the Talent Acquisition / HR team has formally requested your help and have a signed agreement in place. Unsolicited resumes sent to Adverum will be considered property of Adverum. The company will not be...

  • Director of Regulatory Affairs- Strategy

    20 hours ago

    Saint Paul, MN, United States Beacon Hill Staffing Group, LLC Full time

    Beacon Hill Staffing Group, LLC - Director of Regulatory Affairs - Strategy Summary of Position The Director of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. Responsibilities include defining and/or authoring compliant content for new and existing dossiers,...

  • Director, Regulatory Affairs

    6 days ago

    Billerica, MA, United States Parexel International Corporation Full time

    Great opportunity to use your regulatory expertise and lead a truly exceptional team! As a Director, Regulatory Affairs, you will use your expertise to lead and mentor a team of high-performing Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product applications;...

  • Senior Director of Regulatory Affairs

    20 hours ago

    New York, NY, United States Hobson Prior Full time

    Hobson Prior is seeking a motivated Senior Regulatory Affairs Specialist focused on device development. The successful candidate will ensure regulatory compliance and support the development and commercialization of innovative medical devices. This role requires a strong understanding of regulatory requirements and experience in device development within the...

  • Senior Regulatory Affairs Specialist

    4 weeks ago

    Boston, MA, United States Arevna Full time

    Overview of the Role:The Senior Regulatory Specialist provides comprehensive regulatory expertise, supporting daily departmental operations and collaborating with the Manager of Regulatory Affairs to manage global medical device registrations. This role involves ensuring the department’s compliance with regulatory policies and managing both electronic and...

  • Director of Regulatory Affairs

    4 weeks ago

    Gaithersburg, MD, United States Invenia Group Full time

    Invenia is working with a growing manufacturer of scientific instrumentation to hire a Director of Regulatory Affairs.The company manufactures cell biology tools to advance workflows in the cell & gene therapy and bioproduction markets. They have an has an excellent culture and truly value their employees.The role:The Director of Regulatory Affairs will be...

  • Director, Regulatory Affairs CMC

    4 weeks ago

    Rockville, MD, United States Proclinical Staffing Full time

    Director, Regulatory Affairs CMC Permanent - Rockville, MDAre you passionate about driving impactful regulatory strategies in a rapidly evolving environment?Proclinical is working with a leading biotech company dedicated to advancing therapies for unmet medical needs. This role is a fantastic opportunity to make a difference across the entire product...

  • Director, Regulatory Affairs CMC

    1 month ago

    Rockville, MD, United States Proclinical Staffing Full time

    Director, Regulatory Affairs CMC - Permanent - Rockville, MDAre you passionate about driving impactful regulatory strategies in a rapidly evolving environment?Proclinical is working with a leading biotech company dedicated to advancing therapies for unmet medical needs. This role is a fantastic opportunity to make a difference across the entire product...

  • Senior Manager, Regulatory Affairs

    4 weeks ago

    Boston, MA, United States Monte Rosa Therapeutics Full time

    Senior Manager, Regulatory Affairs - CMCLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our teams. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing regulatory strategies to...

  • Senior Regulatory Affairs Consultant

    2 days ago

    Billerica, MA, United States Parexel International Corporation Full time

    If you are passionate about innovative therapies, love leading complex regulatory filings, and live for quality, on time, and within budget project deliverables, Parexel is E-X-P-A-N-D-I-N-G and we currently have openings for Senior Regulatory Affairs Consultants / Regulatory Affairs Leads. These are incredible opportunities to join a tight-knit team of...

  • Associate Director/Director, Biologics CMC Regulatory Affairs

    2 days ago

    Boston, MA, United States Dechra Pharmaceuticals PLC Full time

    Vacancies Associate Director/Director, Biologics CMC Regulatory Affairs Job Introduction This is a US remote role, with a preference for candidates based in the Boston area. Invetx, a division of Dechra , is a veterinary biotechnology company focused on developing protein-based therapeutics for chronic conditions in companion animals, with an emphasis on...