Global Regulatory Manager - En remoto, España - Allucent

Allucent

Empresa verificada

En remoto, España

hace 2 semanas

Publicado por:

Isabel García

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Descripción

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.

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 Startup 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 Startup 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

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
510 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 fastpaced challenging environment of a growing company

Benefits

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 softskills and technical training via GoodHabitz and internal platforms