Senior Regulatory Scientist (Clinical Trial Submissions)

We are expanding our Clinical Trial Submissions (CTS) group and are looking for an experienced Regulatory Affairs professional to join our growing team. This role is ideal for someone with 4+ years of experience in regulatory affairs and a strong background in Clinical Trial Submissions. You’ll have the opportunity to work under a generous, progressive leader who is known for her authentic communication style and her genuine commitment to the growth and development of her team members.

As part of a supportive and collaborative team, you’ll play a key role in driving forward regulatory processes, ensuring compliance, and contributing to innovative clinical trials. This is a chance to grow both professionally and personally in an environment that values your input and expertise.

Role Overview:

• Identify and coordinate the international, national, and local regulatory requirements for clinical trial submissions across various countries.

• Draft, review, and ensure the quality of all documents related to Clinical Trial Application (CTA) dossiers in accordance with local and regional regulations.

• Provide regulatory review of core study documents (e.g., protocols, Investigator’s Brochure, informed consent forms, and labels) to ensure compliance with regulatory standards.

• Perform quality control (QC) on CTA packages before submission to regulatory authorities.

• Maintain and update study status tracking tools, exchanging information with clients and internal teams.

• Draft and QC responses to client inquiries and provide timely, accurate regulatory guidance.

• Create and maintain internal knowledge management tools (e.g., memos, trackers) to support team efficiency and accuracy.

• Collaborate with subject matter experts across various departments (e.g., pharmacovigilance, CMC, nonclinical, clinical) to ensure a seamless, interdisciplinary approach to projects.

• Liaise with regulatory authorities and service providers, under the supervision of the project manager or lead consultant, to support the submission process.

• Lead or participate in regular video/teleconferences with clients to provide status updates on the regulatory progress of their studies.

Requirements

• 4+ years of experience in Regulatory Affairs, with a specific focus on Clinical Trial Submissions (CTS).
• A passion for People, Innovation, Passion, and Excellence (PIPE) – the core values that define our culture and guide how we approach our work.
• Deep understanding of regional and local regulatory requirements for clinical trials, with a proven ability to manage submission packages from start to finish.
• Strong organizational and communication skills, with the ability to collaborate across departments and provide clear regulatory guidance.
• Experience working with regulatory authorities and managing client relationships in a professional setting.
• A proactive approach to problem-solving, with strong attention to detail and the ability to manage multiple projects simultaneously.