(Senior) Regulatory Manager

As a Senior Regulatory Manager at Precision for Medicine, you will guide regulatory strategy for clinical trials, coordinate regulatory submissions, and ensure compliance with industry regulations. Your role will involve preparing documentation for regulatory authorities, leading project teams, and providing input into regulatory strategy for new studies.

To qualify for the Regulatory Manager position at Precision for Medicine, candidates should have a Bachelor's degree in a scientific or healthcare discipline, along with at least 5 years of regulatory experience. For the Senior Manager position, 7 years is required. Familiarity with the drug development process and regulatory milestones is essential.

The Regulatory Manager plays a crucial role in overseeing the regulatory aspects of clinical trials at Precision for Medicine. This includes ensuring timely submissions to regulatory agencies, providing strategic input for study designs, and maintaining compliance throughout the clinical development process.

Success as a Regulatory Manager at Precision for Medicine requires strong interpersonal skills, effective communication abilities, and a deep understanding of regulatory affairs. Additionally, candidates should be self-motivated, skilled in multitasking, and able to lead project teams effectively in a fast-moving environment.

A Regulatory Manager at Precision for Medicine should be computer literate, particularly in MS Office and Office 365. Familiarity with regulatory intelligence tools and project management software is also beneficial for maintaining project plans and trackers.

In response, outline specific regulatory submissions you've prepared, detailing the types such as INDs or CTAs. Highlight your process, key challenges faced, and how you ensured compliance with regulations, demonstrating your expertise and problem-solving skills.

Share an example of a project where you took a leadership role. Discuss your approach to coordinating team efforts, overcoming challenges, and how you ensured that all regulatory requirements were met within deadlines.

Emphasize your methods for staying informed, such as attending industry seminars, subscribing to relevant journals, or participating in professional organizations. Discuss how this knowledge has benefited your previous roles.

Discuss ICH GCP (International Council for Harmonisation Good Clinical Practice) as a critical framework guiding clinical trials. Explain its importance for ensuring ethical treatment of trial participants and data integrity, and how you apply these principles in your work.

Share your approach to conflict resolution, focusing on open communication and finding common ground. Illustrate this with a real-life example where you successfully navigated a disagreement to reach consensus.

Mention any specific tools you've used, explaining how they helped streamline your regulatory processes. Discuss any insights gained from using these tools that improved submission timelines or compliance.

Outline your organized approach to project management, including the use of timelines, regular team check-ins, and prioritizing tasks. Provide an example where your strategy led to a successful and timely submission.

Describe your writing process, emphasizing clarity and thoroughness. Mention your familiarity with various regulatory guidelines that inform your writing and how you ensure quality before submission.

Share a specific challenge related to regulatory approvals. Discuss your thought process, the steps you took to find a solution, and the outcome of your efforts, highlighting your analytical and critical thinking skills.

Express your interest in Precision for Medicine's focus on innovative clinical development, especially in Oncology and Rare Disease. Mention how your skills align with the company's mission and how you can contribute to their success.