Lantheus
Associate Director, Regulatory Affairs, CMC
Lantheus, Bedford, Massachusetts, us, 01730
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 for assigned programs to ensure compliance and coordinate submissions supporting the Company's preclinical/clinical development with a focus on Chemical Manufacturing Controls (CMC) aspects of IND/CTA/IMPD applications. Evaluates proposed regulations and advises on impact of such regulations on the company; provides advice and counsel on cross functional technical teams to support manufacturing, testing and global distribution activities for Lantheus development portfolio in a highly energized and collaborative environment.
Essential Functions
Collaborates with other functional work teams e.g., 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.
Acts as regulatory specialist on development project cross-functional team processes.
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 Technical Operations 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 coordinates responses to health authority questions and comments.
Reviews Technical Operations, and Development documentation for regulatory compliance; including validation protocols, close out reports, analytical methods, batch records and any other CMC related documentation.
Reviews other documentation for regulatory compliance; including FDA IR and responses, and any other Study related documentation.
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 collaborates 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.
Ensure rapid and effective development and review of regulatory documents to be submitted to the FDA and international regulatory agencies.
Typical Minimum Skills and Experience and Education
BS/BA degree in a scientific discipline with a minimum of 5-7+ years of experience in a pharmaceutical industry with a focus on the regulatory perspective for CMC aspects for 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 travelling.
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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 for assigned programs to ensure compliance and coordinate submissions supporting the Company's preclinical/clinical development with a focus on Chemical Manufacturing Controls (CMC) aspects of IND/CTA/IMPD applications. Evaluates proposed regulations and advises on impact of such regulations on the company; provides advice and counsel on cross functional technical teams to support manufacturing, testing and global distribution activities for Lantheus development portfolio in a highly energized and collaborative environment.
Essential Functions
Collaborates with other functional work teams e.g., 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.
Acts as regulatory specialist on development project cross-functional team processes.
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 Technical Operations 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 coordinates responses to health authority questions and comments.
Reviews Technical Operations, and Development documentation for regulatory compliance; including validation protocols, close out reports, analytical methods, batch records and any other CMC related documentation.
Reviews other documentation for regulatory compliance; including FDA IR and responses, and any other Study related documentation.
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 collaborates 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.
Ensure rapid and effective development and review of regulatory documents to be submitted to the FDA and international regulatory agencies.
Typical Minimum Skills and Experience and Education
BS/BA degree in a scientific discipline with a minimum of 5-7+ years of experience in a pharmaceutical industry with a focus on the regulatory perspective for CMC aspects for 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 travelling.
#J-18808-Ljbffr