Allucent is hiring a
Global Regulatory Manager

Summary

The Global Regulatory Manager at Allucent™ is responsible for managing regulatory activities, developing strategies for timely approvals, preparing and submitting local, regional, and global submissions to RAs/IECs/IRBs, and serving as a point of contact for regulatory questions. The ideal candidate should have a Bachelor’s Degree in Healthcare or Biological Science, minimum 3 years of experience in drug development and/or clinical research, 5-10 years of Global Regulatory Submissions experience, strong communication skills, organizational skills, and proficiency with various computer applications. Benefits include comprehensive benefits package per location, competitive salaries per location, departmental study/training budget, flexible working hours, opportunity for remote/hybrid work depending on location, leadership and mentoring opportunities, participation in the Buddy Program, internal growth opportunities, career progression, a financially rewarding employee referral program, access to online soft-skills and technical training, eligibility for Spot Bonus Award Program, and eligibility for Loyalty Award Program.

Requirements

• Bachelor’s Degree in Healthcare or Biological Science
• 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

Responsibilities

• Managing regulatory activities
• Developing strategies for timely 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
• Contributing to the KOM if required to cover aspects related to RA/IEC/IRB submission and approval
• Developing Regulatory and Ethics Submission Plan (RESP)
• Coordinating the preparation of RA/IEC/IRB submission, including amendment submissions
• Planning realistic timelines for submissions and approvals at study & country level
• Acting 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
• Representing the company in interactions with RA/IRB/IEC reviewers to pursue approvals, obtain information, and clarify issues
• Coordinating 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
• Reviewing and finalizing Master SIS/ICF cycle together with Sponsor and/or CBU and distributing approved Master SIS/ICF to the countries
• Overseeing Country and/or Site-Specific (if applicable) SIS/ICF Review/ Finalization and Approval Cycle with Sponsor
• Drafting and contributing 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

Preferred Qualifications

Previous experience in a similar role

Benefits

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our enriching Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees