Senior Manager, Commercial Regulatory - (Remote - US)

As a Senior Manager, Commercial Regulatory at our company, your core responsibilities will include supporting the labeling development process and overseeing regulatory advertising and promotional efforts. You'll be collaborating with various cross-functional teams to ensure all materials meet regulatory standards and align with internal strategies. A crucial part of your role will involve reviewing promotional materials, conducting regulatory intelligence research, and maintaining professional relationships with regulatory experts and health authorities.

To be eligible for the Senior Manager, Commercial Regulatory position at our company, you should possess a Bachelor’s degree in a Life Sciences discipline, with a Master’s degree preferred. Additionally, candidates must have a minimum of 7+ years of experience in regulatory affairs focused on labeling, advertising, or promotion within the Biotech or Pharmaceutical industry. Strong expertise in U.S. labeling requirements and exceptional communication skills are also essential.

The Senior Manager, Commercial Regulatory plays a pivotal role in ensuring that all commercial programs comply with necessary regulatory guidelines, which directly impacts their success. By providing regulatory input on promotional concepts, reviewing labeling, and collaborating with cross-functional teams, you will help produce compliant promotional materials that resonate with business objectives. Your insights and thorough understanding of regulations will safeguard the integrity of our product initiatives.

At our company, the work environment for the Senior Manager, Commercial Regulatory is supportive and inclusive, promoting both professional and personal growth. You'll have the chance to engage with talented individuals across various departments, ensuring teamwork and collaboration. The remote setting offers flexibility, allowing you to efficiently manage your work-life balance while focusing on achieving shared goals.

As a Senior Manager, Commercial Regulatory, you can expect a comprehensive benefits package that includes premium health, financial, work-life, and wellness offerings for you and your dependents. We support our employees with generous paid time off, life insurance, disability coverage, retirement plans with employer match, and opportunities for short-term and long-term incentive compensation, along with company stock options.

When discussing your experience, be specific about the roles you've worked in that focus on regulatory compliance, particularly in the areas of labeling and promotions. Detail any projects where you successfully reviewed promotional materials or influenced product labeling strategies to align with regulations, emphasizing your understanding of the implications of changes made.

In your response, provide examples of how you've worked with various teams—such as marketing, medical affairs, or legal—to ensure compliance. Highlight specific projects where communication and collaboration were key to navigating regulatory challenges and achieving a common goal, illustrating your team-oriented mindset.

Discuss your methods for keeping up to date on regulatory changes, such as attending industry conferences, subscribing to regulatory newsletters, or being part of relevant associations. Mention any specific resources you regularly consult and how you implement this knowledge in your work, showcasing your proactive approach to staying informed.

Emphasize your organizational skills and methods for prioritizing tasks. You might mention using project management tools or techniques like the Eisenhower Matrix for effective time management. Provide examples from previous roles where your multitasking skills benefited project outcomes, thereby illustrating your ability to thrive under pressure.

Share a specific instance where you encountered a complex regulatory issue, detailing the steps you took to approach the problem. Focus on your analytical skills, the resources you leveraged, and how you communicated solutions to stakeholders, highlighting your problem-solving capabilities in the regulatory landscape.

Provide a comprehensive overview of your understanding of U.S. labeling requirements. Touch on key regulations you’re familiar with, including FDA guidelines. Give examples of how this understanding has played a role in your work, particularly in ensuring compliance and quality in promotional materials.

Discuss your approach to analyzing the implications that labeling changes may have on pending or approved labels. Mention any tools or frameworks you use to assess risks and benefits, and how you communicate these analyses to affected teams, indicating your thorough analysis skills.

Explain how regulatory intelligence informs your decision-making and strategic planning. Illustrate your process for conducting regulatory research, particularly how it helps you identify potential challenges or opportunities in the regulatory landscape, and how you disseminate your findings to relevant teams.

Detail the steps you take to evaluate promotional materials against regulatory standards, including any review processes you've implemented in prior roles. Describe how you collaborate with other departments to ensure compliance is at the forefront of all promotional strategies, ensuring successful product messaging.

Reflect on what drives your passion for regulatory affairs, perhaps focusing on the importance of safe and effective medication reaching the market or the ever-evolving regulatory landscape. Share insights on how these motivations sustain your commitment to excellence in your work, which in turn empowers your colleagues and the organization.