Senior Director Regulatory Affairs
5 days ago
Lantheus Medical Imaging Inc is seeking an experienced Senior Director to lead our Regulatory Affairs team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to drive business growth.
Key Responsibilities:- Lead and manage a team of direct reports, providing guidance and coaching to ensure successful project delivery.
- Collaborate with cross-functional teams to develop and implement regulatory strategies, including promotional and disease awareness communications.
- Act as Lantheus liaison to the FDA's Office of Prescription Drug Promotion (OPDP), preparing correspondence and conducting negotiations.
- Monitor new or revised legislation, regulations, and guidance documents, analyzing and communicating their relevance to the team.
- Oversee the preparation and maintenance of regulatory labeling for multiple products across therapeutic areas.
- PharmD/PhD with 8+ years' relevant experience, or MA/MS/MBA with 12+ years' relevant experience, or BA/BS with 14+ years' relevant experience.
- Extensive experience in prescription drug labeling, regulatory compliance, and leadership.
- Strong track record of successfully managing large-scale, complex projects and cultivating strategic relationships.
- 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 Medical Imaging Inc is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a dynamic environment that contributes to our success.
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