Senior Regulatory Counsel

hace 17 horas


Xico, México Syneos - Clinical And Corporate - Prod A tiempo completo
Job Summary

We are seeking a highly skilled and experienced Senior Regulatory Counsel to join our team. As a key member of our Legal Regulatory function, you will provide expert legal and regulatory advice on global regulatory and clinical development matters.

Your primary responsibilities will include:

  • Assisting the Head of Legal Regulatory in developing and implementing the Legal Regulatory strategy in alignment with departmental and functional goals and company strategy.
  • Providing legal and regulatory advice to Corporate Quality and the clinical business on quality-related issues, regulatory authority inspections, client and internal audits.
  • Supporting the Dispute Resolution team on litigation and pre-litigation matters as appropriate.
  • Providing legal support for communications with regulatory agencies.
  • Supporting compliance and quality investigations as appropriate.
  • Assisting the Head of Legal Regulatory in advising the business on new and modified service offerings.
  • Supporting regulatory due diligence in connection with potential M&A or other business transactions.
  • Staying up-to-date with legislative and regulatory changes that may affect the company and its customers.
  • Advising on regulatory and Quality Assurance commitments in clinical and commercial agreements.
  • Collaborating with the Legal department, including the Company's global team of regional-based attorneys, in providing legal regulatory advice, building consensus on process improvements, and driving corporate legal projects to completion.

Requirements

  • Fully qualified lawyer with 8+ years of experience advising on legal and regulatory matters in the pharmaceutical research and development space.
  • Broad understanding of the clinical trials regulatory framework, with awareness of key differences across international jurisdictions.
  • Strong working knowledge of GxP requirements applicable to clinical research, with a particular focus on GCP and GVP.
  • Ability to communicate clearly, concisely, and professionally with all levels of management regarding complex regulatory issues.
  • Experience working in a healthcare or life sciences company, such as a CRO, biotech, or pharmaceutical drug development company.
  • Ability to work independently while being able to contribute successfully to cross-functional teams.
  • Independent judgment, attention to detail, a desire to learn, and an ability to take on and prioritize a wide variety of complex matters in a fast-paced environment.
  • Can-do attitude, ability to work under pressure and to manage the expectations of clients.
  • Creative problem-solving ability with a focus on achieving client-friendly solutions while managing company risk.
  • Sense of humour is a plus.

About Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health


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