Director of Regulatory Affairs Strategy

Lantheus

. Work collaboratively on a range of cross-functional project teams, providing current regulatory perspectives and considerations.

Posted 4/22/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesLead💰 $172,000 - $287,000 per yearWebsite

About the role

Key responsibilities & impact

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 driving development and approval of company assets.
Drive and manage submission plans for IND/CTA/IMPD/NDA applications.
Manage concurrent regulatory projects and respond timely to deadlines.
Collaborate with internal and external partners to ensure regulatory documentation meets requirements.
Execute on compilation of regulatory submissions including annual reports, and amendments and supplements.
Review Technical Operations and Development documentation for regulatory compliance.
Coordinate responses to health authority agencies' requests for information.

Requirements

What you’ll need

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.
Strong organizational and planning skills.
Ability to communicate effectively and efficiently to multiple audiences.

Benefits

Comp & perks

Comprehensive health benefits package including medical, prescription drug, dental, and vision coverage.
Life and disability benefits.
Pre-tax accounts.
401(k) with company contribution.
Generous time off package including paid vacation, holidays, sick days, and paid parental leave.

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Hard Skills & Tools

regulatory submissionsIND applicationsCTA applicationsIMPD applicationsNDA applicationsregulatory complianceregulatory documentationtechnical operations reviewannual reports compilationamendments and supplements

Soft Skills

collaborationorganizational skillsplanning skillscommunication skillstime management

Certifications

BS degreeBA degreeMS degreePhD degree