Senior Regulatory Counsel

hace 2 semanas

Ecatepec de Morelos, México Syneos Health Clinical A tiempo completo

**Job Summary**

**Responsibilities**:

Provide expert legal and regulatory advice on global regulatory and clinical development matters to support the growth and success of Syneos Health Clinical.

Assist the Head of Legal Regulatory in developing and implementing the Legal Regulatory function's strategy, ensuring alignment with departmental and functional goals and company objectives.

Collaborate with Corporate Quality and the clinical business to provide legal and regulatory advice on quality-related issues, regulatory authority inspections, client and internal audits.

Support the Dispute Resolution team on litigation and pre-litigation matters as needed.

Provide legal support for communications with regulatory agencies and assist with compliance and quality investigations.

Stay up-to-date with legislative and regulatory changes affecting the company and its customers, providing expert advice on regulatory and Quality Assurance commitments in clinical and commercial agreements.

Work closely with the Legal department, including the global team of regional-based attorneys, to provide legal regulatory advice, build consensus on process improvements, and drive corporate legal projects to completion.

**Qualifications**

**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 focus on GCP and GVP.

Ability to communicate complex regulatory issues clearly, concisely, and professionally with all levels of management.

Experience working in a healthcare or life sciences company, such as a CRO, biotech, or pharmaceutical drug development company.

Ability to work independently while contributing to cross-functional teams.

Independent judgment, attention to detail, and a desire to learn and take on complex matters in a fast-paced environment.

Can-do attitude, ability to work under pressure, and manage client expectations.

Creative problem-solving ability with a focus on achieving client-friendly solutions while managing company risk.

**Why Syneos Health**

We are passionate about developing our people through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and a total rewards program.

We are committed to our Total Self culture, where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels like they belong.

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