REMOTE Regulatory Affairs Principal Strategist - Clinical Operations

The REMOTE Regulatory Affairs Principal Strategist - Clinical Operations at ClinChoice is responsible for developing and implementing regulatory submission strategies for global clinical trials. This involves leading regulatory activities, providing strategic input for clinical trial submissions, and managing interactions with regulatory authorities to ensure compliance with guidelines.

To qualify for the REMOTE Regulatory Affairs Principal Strategist - Clinical Operations role at ClinChoice, candidates should have a Bachelor's degree in a scientific discipline and a minimum of 8 years of regulatory experience in the pharmaceutical or biotechnology industry, especially in the clinical development phase.

The REMOTE Regulatory Affairs Principal Strategist plays a crucial role in advancing ClinChoice's mission to enhance global healthcare by developing effective regulatory strategies that facilitate the timely and compliant progression of clinical trials, thereby accelerating the development and commercialization of innovative drugs and devices.

Preferred skills for this role include experience with global regulatory submissions, strong communication and leadership abilities, knowledge of drug and medical device regulations, as well as proficiency in managing multiple projects in a fast-paced environment.

As the REMOTE Regulatory Affairs Principal Strategist at ClinChoice, you'll work on a variety of projects involving clients from small biotechnology startups to large pharmaceutical organizations, focusing on developing and managing regulatory submission strategies for clinical trials.

In answering this question, focus on specific regulatory submissions you have managed, detailing the processes involved, challenges faced, and how you ensured compliance with global standards. Illustrate your experience with metrics or outcomes where possible.

Express your commitment to continuous professional development by mentioning specific resources, such as online courses, regulatory agency updates, and professional organizations you engage with to remain informed about regulatory changes.

Provide a detailed account of a specific regulatory challenge you faced, your approach to resolving it, and the successful outcome. Highlight your problem-solving and analytical skills in the context of regulatory strategy.

Discuss the importance of working with other departments, such as clinical operations and research, to align on regulatory strategies. Include examples of successful collaborations that resulted in enhanced project outcomes.

Share a narrative that includes the regulatory authority's requirements, how you prepared for the interaction, and the impact of your engagement on the project. Emphasize your communication and negotiation skills.

Demonstrate your organizational skills by outlining specific methodologies, such as prioritizing based on deadlines, utilizing project management tools, and delegating tasks when necessary to maintain efficiency.

Explain your process for integrating company goals into regulatory strategies. Provide examples where you've successfully aligned regulatory requirements with broader business objectives.

Discuss specific challenges encountered, such as changes in regulations or issues with the EU CTIS portal, and how you successfully navigated these challenges to ensure timely submissions.

Identify the key elements of a strong regulatory submission strategy, such as thorough understanding of regulatory requirements, stakeholder communication, and strategic planning, explaining why each component is essential.

Describe your systematic approach to gathering regulatory intelligence, including the tools and resources you utilize, and how you translate that information into actionable strategies for new product submissions.