Senior Regulatory Counsel

hace 2 meses


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

Syneos Health is a leading biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our company culture is based on teamwork, with every role vital to furthering our vision of Shortening the Distance from Lab to Life. Our 29,000 employees across 110 countries already know that working at Syneos Health matters everywhere.

We are passionate about developing our people through career development and progression, technical and therapeutic area training, peer recognition, and a total rewards program. Our Total Self culture unites us globally, and we are dedicated to taking care of our people.

Job Summary:

The Senior Regulatory Counsel will provide legal and regulatory advice on global regulatory and clinical development matters. Key responsibilities include assisting the Head of Legal Regulatory in strategy and implementation, providing legal and regulatory advice to Corporate Quality and the clinical business, and supporting dispute resolution and compliance investigations.

Responsibilities:

  • Provide legal and regulatory advice on global regulatory and clinical development matters
  • Assist the Head of Legal Regulatory in strategy and implementation of the Legal Regulatory function
  • Provide legal and regulatory advice to Corporate Quality and the clinical business on quality-related issues, regulatory authority inspections, client and internal audits
  • Support dispute resolution and compliance investigations as appropriate
  • Advising on new and modified service offerings
  • Supporting regulatory due diligence in connection with potential M&A or other business transactions

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

Compensation: $140,000 - $160,000 per year

Why Work at Syneos Health?

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 and discover why our employees already know that working here matters everywhere.



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