Regulatory Affairs Operational Support

I am working with a globally recognized regulatory specialist organization that are experienced in supporting end-to-end regulatory solutions for the life science industry. From regulatory affairs and pharmacovigilance to clinical research and quality management, this company provide expert services paving the way for seamless compliance.

The company are currently seeking to appoint a Regulatory Affairs Operational Support to facilitate and contribute to the successful global operations.

The key responsibilities in this role will include:

• Coordinate and ensure the timely completion and approval of submission documents for regulatory compliance, following a content plan and established timelines.
• Monitor and facilitate the workflow of document creation, including holding roundtable meetings for collaboration and resolving comments.
• Verify the accuracy and completeness of submission documents, ensuring critical hyperlinks are functional.
• Track and manage various regulatory activities, such as correspondence, safety reports, clinical trial approvals, and variations, using internal trackers and systems.
• Prepare and coordinate the submission of regulatory packages, including cover letters, application forms, and supporting documentation.
• Collaborate with cross-functional teams, internal stakeholders, and regulatory authorities to address queries, coordinate responses, and fulfill post-approval commitments.
• Maintain accurate records in regulatory information management systems, including data entry, verification, and updates.
• Liaise with Global Regulatory Leads (GRL) and stakeholders to gather required information, review documents, and facilitate regulatory processes in compliance with internal procedures and standards.

To be successful at interview candidates must have the following experience:

• 2-6 years’ experience with regulatory operations and submission
• Expert knowledge and understanding of eCTD submission requirements
• Independent worker and strong ability to collaborate with a global team
• Strong Clinical Trials Application/New Drug submission experience 
• Expert knowledge and ability to ensure submissions are in accordance to ICH and FDA guidelines 
• All EU submission experience 

If this sounds like an opportunity you want to be a part of, then get in contact today!