(Senior) Regulatory Manager

To become a Senior Regulatory Manager at Precision for Medicine, candidates should hold a bachelor's degree in a scientific or healthcare discipline, with a preference for those with graduate or postgraduate education. You’ll need at least seven years of regulatory experience, ideally within a Clinical Research Organization, with proven leadership in clinical submissions.

As a Regulatory Manager at Precision for Medicine, your primary responsibilities will include providing regulatory guidance throughout the clinical development life cycle, compiling and reviewing applications for Regulatory Authorities, serving as a representative at project meetings, and overseeing the work of regulatory specialists to ensure submission targets are met.

Individuals in the Regulatory Manager position at Precision for Medicine often progress to Senior Regulatory Manager roles, depending on experience and performance. Gaining further expertise in global regulatory strategies and complex clinical submissions can also lead to opportunities in higher management and leadership positions within the organization.

Success as a Senior Regulatory Manager at Precision for Medicine requires strong interpersonal skills, the ability to manage multiple tasks efficiently, deep knowledge of regulatory standards, and the ability to effectively communicate insights both verbally and in writing. A proactive approach to problem-solving and team collaboration is also highly valued.

Precision for Medicine offers extensive support for the career development of its Regulatory Managers through mentorship opportunities, continuous training, and a culture that encourages personal growth. The company is dedicated to fostering talent and providing resources that help employees stay updated on evolving regulatory environments.

When answering this question, highlight the types of submissions you have worked on, like INDs or CTAs. Describe your role in the process, challenges faced, and how you ensured compliance. Drawing specific examples will showcase your hands-on experience effectively.

Discuss the resources you use to keep up-to-date, such as regulatory websites, professional organizations, and networking with other regulatory professionals. Mention any specific seminars or training sessions that you attend regularly to enhance your knowledge.

Use the STAR method (Situation, Task, Action, Result) to frame your answer. Focus on a specific challenge, what your task was, the actions you took to resolve it, and the positive outcomes that followed. This shows your analytical and problem-solving abilities.

Highlight your communication techniques and tools you use for project management. Discuss your approach to maintain alignment in the team's efforts and how you ensure that everyone understands their roles and deadlines for successful submissions.

Talk about the various factors you assess, such as the therapeutic area, regulatory requirements, timelines, and the landscape of similar submissions. This question allows you to showcase your strategic thinking skills.

Demonstrate your ability to assess urgency and importance by explaining your prioritization process. You could describe any tools or methods you use (like a task tracking software) that help in managing multiple deadlines effectively.

You could emphasize that as a Regulatory Manager, your role involves ensuring the clinical trial complies with applicable regulations and guidance, potentially influencing the design based on regulatory requirements and scientific understanding.

Share a specific situation where you provided training or guidance to team members. Describe the context, your approach, and the outcome, showcasing your leadership and mentorship capabilities.

Discuss your specific involvement in either area, detailing your understanding of the process, any submissions you’ve worked on, and how you navigated regulatory requirements in these specific fields.

Discuss your conflict resolution techniques, focusing on your ability to listen to differing perspectives, facilitate discussions to reach a consensus, and remain professional to ensure productive meetings.