Regulatory Affairs Manager, Advertising and Promotion

Lantheus Brand • Bedford, MA

1d • $111,000 - $185,000 • Hybrid

About The Position

Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus, we are purpose-driven, and every employee plays a vital role in our success. We’re dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone’s health is in our hands. Summary of role We are seeking a Manager-level professional in Regulatory Affairs, Advertising and Promotion. This role will be responsible for ensuring that promotional, advertising, and healthcare communications for one or two marketed products comply with FDA regulations, industry standards, and internal company policies. This role collaborates closely with Marketing, Medical Affairs, Legal, and other cross-functional partners to provide timely and strategic regulatory guidance throughout the development, review, and approval of promotional materials. Success in this position requires a strong understanding of FDA regulations related to prescription drug and medical product promotion, as well as excellent communication, collaboration, and decision-making skills to effectively balance business objectives with regulatory risk. This position is based in Massachusetts and requires a presence on-site (two/three) days per week, and open to applicants authorized to work for any employer within the United States.

Requirements

• Requires a BA/BS degree in a scientific discipline; advanced scientific degree preferred (i.e. Pharm D, NP, PA,)
• Minimum 1 or 2 years of Pharmaceutical/Biotech industry experience; will consider pharm D fellow who completed fellowship in pharmaceutical /biotech company
• Excellent verbal, written communication skills.
• Strong attention to detail with the ability to check documents for accuracy as well as consistency.
• Ability to navigate complex regulatory framework while remaining solutions-oriented to address corporate objectives.
• Knowledge of clinical study design and statistical analyses in the assessment of promotional claims.
• Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders.
• Consistently meets deadlines without compromise to work.
• Ability to distill complexity into understandable and actionable language.
• Willingness to travel to various meetings or sites, including overnight trips (if needed).
• Demonstrate cross-functional people management with a desire to foster a positive team culture.
• Ability to work independently and take initiative
• Adapt in guiding teams through complex advertising and promotion processes with a focus on patient safety and compliance.

Nice To Haves

• Leadership Skills - can lead and motivate team members. Develops, uses and shares knowledge and uses strong interpersonal skills to guide others.
• Strategic Approach – ability to identify, create and implement processes for the review of Promotional and Disease awareness materials.
• Change Management — ability to identify, advocate and implement change positively for the organizations. Demonstrates flexibility and the ability to accommodate change.
• Analytical and Problem-Solving Skills - Excellent ability to understand complex issues and propose achievable solutions.
• Interpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement.
• Teamwork - the ability to work well in a highly cross-functional team environment.
• Presentation skills — create and deliver presentations with appropriate messaging and focused recommendations.

Responsibilities

• Act as the Subject Matter Expert for assigned products and projects focusing on advertising and promotion regulatory affairs.
• Be the Regulatory Advisor and function as the “R” in the core Medical, Legal, and Regulatory review functions within the Promotional Review Process (PRC).
• Provide regulatory guidance during development, review, approval, and implementation of medical and commercial materials.
• Be product or project business lead for one or more established marketed products at Lantheus.
• Be a strategic business partner from clinical trial development through the marketing maintenance phase of a product lifecycle.
• Evaluate promotional concepts and materials for scientific accuracy, regulatory risk, and consistency with product labeling.
• Monitor regulatory trends and enforcement actions
• Be an ad/promo regulatory subject matter expert on FDA, EFPIA (preferred) and IFPMA (preferred) code/regs, guidance, industry standards, complaints/violations, and innovative promotional platforms
• Exercise decision-making authority within the PRC to ensure compliance, patient safety, and alignment with Lantheus’ values.

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: Manager