Director of Regulatory Affairs Strategy

Lantheus • Bedford, MA

1d • $172,000 - $287,000 • Onsite

About The Position

The Director of Regulatory Affairs Strategy is responsible for integrating and
applying knowledge of global regulations governing radiopharmaceutical drug
development for assigned programs to advance the development and
commercialization of the Company’s portfolio of assets. The Director will have
responsibility for leading regulatory strategies for assigned programs.

This position is based in Bedford, MA or Springfield, NJ and requires a presence
on-site of three days per week. It is open to applicants authorized to work for
any employer within the United States.

Requirements

• BS/BA degree in a scientific discipline. MS/PhD preferred.
• Minimum of 7 to 10 years of experience in the pharmaceutical industry including leading programs through regulatory submissions. Experience with radiopharmaceuticals preferred but not required.
• Experience with 21 CFR 212 (i.e. PET Radiopharmaceutical Regulations) is a plus

Responsibilities

• Work collaboratively on a range of cross-functional project teams, providing current regulatory perspectives and considerations. Make recommendations to progress programs while ensuring compliance with regulations and applicable guidance.
• Serve as the Regulatory lead on asset teams that are driving development and ultimate approval of company assets. This includes regulatory strategy development, regulatory agency engagements, submission plan development and execution.
• Drive and manage the submission plans and authoring of content for assigned programs for IND/CTA/IMPD/NDA applications, including meeting requests, briefing documents, etc.
• Manage a range of concurrent regulatory projects and issues and respond timely to ensure due dates are met.
• Closely collaborate with key partners both internal and external to the company, aimed at ensuring regulatory documentation meets requirements and due dates.
• Execute on compilation of regulatory submissions including annual reports, and necessary amendments and supplements.
• Review Technical Operations, and Development documentation intended to support IND/CTA/IMPD/NDA applications for regulatory compliance.
• Coordinate responses to health authority agencies request for information and/or questions in a timely manner.
• Interact directly with the FDA and with other Health Authorities responding to technical regulatory questions related to clinical strategy.
• Serves as the primary contact for IND/CTA/IMPD/NDA filing materials and questions for assigned programs, ensuring they are completed in accordance with regulations.
• Perform literature searches, prepares reports and assembles documentation to support project teams as required.
• Strong organizational and planning skills, and ability to communicate effectively and efficiently to multiple audiences.

Benefits

• Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award.
• Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage.
• Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits.
• In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Director