The Global Regulatory Manager is responsible for managing regulatory activities, developing and implementing strategies for timely (regulatory) approvals, ensuring timely preparation and submission of local, regional and global submissions to RAs/IECs/IRBs, ensuring the quality, content and format of regulatory submissions; serving as a direct point of contact for regulatory questions raised by the Sponsor, client’s Senior Leadership team, Business Development, Auditors and Inspectors. The GRA is a member of the Study Start-Up & Site Intelligence unit.
This position is fully remote.
Key Responsibilities
• Contributes to the KOM if required to cover aspects related to RA/IEC/IRB submission and approval.
• Develop Regulatory and Ethics Submission Plan (RESP)
• Coordinate the preparation of RA/IEC/IRB submission, including amendment submissions: will work alongside the Global Start-up Manager/PM ensuring submissions are performed according to internal and client expectations.
• Plan realistic timelines for submissions and approvals at study & country level
• Act as a source of information for Sponsors, Senior Leadership, Global Study Start-up Managers, Pharmacovigilance, Business Development, Auditors and/or Inspectors for Regulatory Requirements in countries participating in a clinical trial
• Represent the company in interactions with RA/IRB/IEC reviewers to pursue approvals, obtain information, and clarify issues
• Coordinate the Site Activation Specialists, Global Submission Specialists and Global Start-Up Assistants during preparation, compilation and submission to RA/IEC/IRB until the corresponding approvals are in place
• Review and finalize Master SIS/ICF cycle together with Sponsor and/or CBU and distribute approved Master SIS/ICF to the countries
• Oversee Country and/or Site-Specific (*if applicable) SIS/ICF Review/ Finalization and Approval Cycle with Sponsor
• Draft and contribute as Subject Matter Expert (SME) in the field of Regulatory Oversight activities to the evaluation/improvement of processes and procedures within the Quality Management System
Key Requirements
• Bachelor’s Degree in Healthcare or Biological Science and minimum 3 years of experience in drug development and/or clinical research; or equivalent combination of education, training, and experience
• 5-10 years of Global Regulatory Submissions experience
• Thorough knowledge of GxP, GDPR, EU CTR and EU CTD and applicable (local) regulatory requirements
• Previous sponsor facing experience a significant advantage
• Good understanding of Regulatory Submission requirements, preferably through several years of Submission experience.
• Strong written and verbal communication skills including good command of English language
• Strong organizational skills
• Representative, outgoing and client focused
• Ability to work in a fast-paced challenging environment of a growing company
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required
