Associate Director, US Regulatory Policy

As an Associate Director, US Regulatory Policy at Novartis, you will be crucial in monitoring regulatory developments and assessing their impact on the organization. Your responsibilities will include providing strategic advice to senior management, supporting regulatory intelligence efforts, establishing relationships with key stakeholders, and preparing regulatory reports and presentations. You'll also collaborate with cross-functional teams to integrate regulatory considerations into business planning and ensure effective communication across different departments.

To qualify for the Associate Director, US Regulatory Policy position at Novartis, candidates should have a science-based BS or MS degree, with an advanced degree like an MD, PhD, or PharmD being advantageous. A strong background in regulatory and/or drug/biologic development is essential, along with 4-6 years of relevant experience, particularly in a global or matrix environment. Strong problem-solving, analytical, and communication skills are also critical for effectively navigating the regulatory landscape.

At Novartis, we believe in fostering a dynamic work environment where employees can thrive. For Associate Directors in Regulatory Policy, opportunities for career growth are abundant. You can engage in cross-functional collaborations, participate in external working groups, and attend training on new regulations, all while working towards strategic objectives that align with your career aspirations. The organization encourages continuous learning, supporting both professional and personal development.

The work environment for an Associate Director, US Regulatory Policy at Novartis is collaborative and innovative. You’ll work in a hybrid setting that allows flexibility while fostering teamwork and communication with diverse groups. Your role will engage you in discussions with regulatory authorities and industry bodies, ensuring you are at the forefront of the evolving regulatory landscape. Novartis is committed to creating an inclusive culture that values diverse perspectives.

Novartis offers a comprehensive benefits package for the Associate Director, US Regulatory Policy position, which includes competitive salary ranges of $145,600 to $270,400 per year, along with bonuses and restricted stock options. Other benefits include a full suite of medical options, 401(k) eligibility, generous paid time off policies, and professional development programs. These offerings reflect our commitment to supporting your well-being and career advancement.

When discussing your experience with regulatory compliance, it's essential to highlight specific projects where you successfully navigated regulatory frameworks. Provide examples that showcase your understanding of compliance regulations and your ability to implement policies that align with regulatory requirements in previous roles.

To effectively answer this question, share the methods you use to stay informed of regulatory changes. This can include following relevant publications, attending industry conferences, participating in webinars, and being active in professional associations. Emphasize your proactive approach to learning and adapting to new regulations.

When answering this question, choose a specific challenge you faced in your previous role and discuss how you approached it. Highlight the steps you took to analyze the issue, collaborate with stakeholders, and communicate effectively, focusing on the resolution and positive outcome.

Your answer should reflect your organizational skills and ability to differentiate between urgent and important tasks. Discuss a method you use, such as project management tools or setting clear timelines, to streamline your work and ensure that regulatory requirements are met in a timely manner.

In your answer, emphasize the importance of simplifying complex information. Share your strategies for breaking down regulatory information into understandable terms, using analogies or visuals when appropriate. Mention past experiences where you successfully communicated with diverse audiences.

Discuss the significance of relationship-building in the regulatory landscape. Emphasize how an Associate Director can act as a liaison between the company and regulatory authorities, fostering open communication that supports compliance and helps anticipate regulatory changes.

Give an example of a past project where you collaborated with multiple departments. Discuss your role, the challenges faced, and how you facilitated communication and teamwork to achieve project goals, highlighting your ability to navigate cross-functional dynamics.

Outline the steps you take in risk assessment, such as identifying potential regulatory risks, evaluating their impact, and proposing mitigation strategies. Share an example where your risk assessment positively impacted a project or decision-making process.

Discuss the metrics you use to evaluate regulatory successes, such as compliance rate, stakeholder satisfaction, or project timelines. Illustrate your measurement methods with examples from previous roles that showcase your ability to assess effectiveness.

Your response should reflect your passion for the pharmaceutical industry and commitment to making a difference in patients' lives. Mention specific aspects of Novartis that attract you, such as their innovative culture, commitment to patient health, or focus on community collaboration, reinforcing your enthusiasm for the role.