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CAREERS

We are looking for professionals who want to be part of a dynamic company, with a friendly and welcoming workplace culture: professionals with an innovative mindset, the flexibility to easily adapt to changes, who are dynamic, purposeful, passionate, and committed to our mission. We want leaders, individuals of integrity, who are willing to deliver excellent, high-quality results.

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We are looking for a Regulatory Director

You will lead and develop regional regulatory strategies to expand the business from the regulatory side, maximize regulatory and ethical committee approval success, and redefine the team´s purpose.


Functions:

  • Responsible for managing direct reports and overseeing all LATAM regional submissions for assigned

    projects, including the leadership of the Regulatory team for the preparation, submission, and

    management of regulatory and ethics documentation for clinical trials to ensure timely and high-

    quality submissions.

  • Monitor and anticipate trends that impact both the regulatory and access environments to strengthen

    regional regulatory strategies in a timely manner.

  • Provide regulatory strategy support for licensing opportunities as appropriate.

  • Partner with direct reports to ensure assigned project strategies are being addressed and provide

    senior strategic input to interactions with regulatory/health agency as applicable.

  • Provide strategic regulatory input to regional teams cross-functional teams for new projects and

    business initiatives.

  • Responsible for the development of regional regulatory strategies that de-risk and accelerate the

    submission and approval of clinical trials by Ethics Committee and MoH, including the set up and

    maintenance of a Regional Regulatory Strategy Intelligence within the company.

  • Lead regulatory risk assessment, identify key regulatory issues and mitigation activities, including

    discussing with direct reports and management for implementation of solutions.


Requirements:

  • Proven expertise in managing regulatory areas in Latin America specifically in CRO and/or Pharma companies.

  • Strong leadership skills in handling key internal and external stakeholders

  • Bachelor's degree, preferably in (life) sciences. Master´s degree is a plus.

  • With 10+ years of industry/CRO experience in Regulatory Affairs

  • Extensive experience in interacting/negotiating with MoH Agencies

  • Senior management experience in Regulatory Affairs or related field, leading a medium to large organization and influencing senior-level management and key stakeholders.

  • Strong understanding of the drug development process, including preclinical, clinical, and regulatory requirements

If you are fueled by passion for Regulatory Affairs, and you possess the drive to craft impactful strategies, don't miss out on this chance to elevate your career and contribute to groundbreaking initiatives. Apply now and be a part of shaping VaxTrial's future.



 



 
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Vax Next Generation

Stay connected!  When new positions open up, or if we start accepting open applications for our talent pool again, we offer the possibility to keep your CV in our data base.

 

Are you health professional interested in clinical research? Vax Next Generation training program is designed to comprehensively cover the world of clinical research.

 

Pensum
 
 

Vax Next Generation Program

 
 

How to prepare for the best remote job

 
 
A benefit of starting to work in clinical research
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