Associate Director, Regulatory Affairs

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

Responsible for integrating and applying knowledge of global regulations governing radiopharmaceutical drug development supporting the Company's preclinical / clinical development / commercial programs, including, developing regulatory strategy for all phases of drug development in order to progress regulatory / business objectives.

Responsible for the coordination and preparation of document packages for lND / NDA / CTA / IMPD applications. Evaluates proposed regulations and advises on impact of such regulations on the company;

provides regulatory advice and counsel on cross functional teams to support Lantheus' development portfolio in a highly energized and collaborative environment.

Key Responsibilities / Essential Functions

• Collaborates with other functional work teams eg., Preclinical, Clinical, Medical Affairs, Manufacturing and Quality Control, providing regulatory guidance to aid in preparing, reviewing, and approving of regulatory NDA / IND / CTA / IMPD submissions materials.
• Manages a range of concurrent regulatory projects, and issues, and responds timely to ensure regulatory submissions are reviewed and approved to meet project target dates.
• Provides a current knowledge of regulatory perspectives and considerations to a range of internal functional work teams.
• Serve on a range of cross-functional team processes, providing current regulatory perspectives and considerations. Make recommendations aimed at ensuring compliance.
• Maintains responsibility for the regulatory strategy related to maintenance of NDA / IND / CTA / IMPD applications and pre-market therapeutic and diagnostic imaging product offerings.
• Closely collaborates with R&D, Clinical team members, and other key partners both internal and external to the company, aimed at ensuring regulatory documentation meets project target dates.
• Executes compilation of IND and NDA regulatory submissions including annual reports, amendments and coordinate responses to health authority questions and comments.
• Reviews Clinical and Development documentation including study related documentation for regulatory
• Reviews other documentation for regulatory compliance; including FDA IR and responses, and any other Study related documentation.
• Collaborates with team members for the development of materials for Agency meetings.
• Prepares and oversees regulatory project timelines.
• With supervision, may interact directly with the FDA and with other Health Authorities through local regulatory managers, responding to technical regulatory questions related to clinical strategy.
• Serves as the primary contact for IND / NDA documentation materials and questions, ensuring they are completed in accordance with regulations, and collaborate on final versions.
• Has a good understanding of the development products and Health Authority guidance to impart beneficial, operational regulatory advice to a range of internal functional partners.
• Maintains current knowledge of and ensures all work activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures.
• Actively maintains and demonstrates the Lantheus values.
• Ensure rapid and effective development and review of regulatory documents to be submitted to the FDA and international regulatory agencies.

Basic Qualifications

• BS / BA degree in a scientific discipline with a minimum of 5-7+ years of experience in the pharmaceutical industry with a focus on the regulatory perspective related to radiopharmaceuticals, or equivalent.
• Experience with 21 CFR 212 (i.e. PET Radiopharmaceutical Regulations) is a plus.
• Veeva RIM experience is a plus.

Other Requirements

• Non-routine travel based on business need
• This position is site-based and requires a presence on-site of 3 days per week in Bedford, MA when not traveling.

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 [email protected] .

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