Global Regulatory ManagerPosizione Aperta
Candidatura valida entro il:11/04/2024
Annuncio inserito il:11/02/2024
PosizioneGlobal Regulatory Manager
Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.
These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.
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, Allucent’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.
• 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
• 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
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Internal growth opportunities and career progression
• More task variety
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms