Senior Vice President - Regulatory Affairs and Safety Management

Company
Synteract
Location
United States
Salary
Competitive
Posted
22 Apr 2021
Closes
22 May 2021
Ref
28923
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Senior Vice President - Regulatory Affairs and Safety Management - Anywhere, US

Remote

Who We Are

Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. We provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.

Specific tasks would include:
  • Drive opportunities for regulatory, safety and clinical strategic consulting activities.
  • Provide strategic regulatory, safety and clinical input to other departments and management (proposal development and project execution oversight in the field of regulatory and clinical consulting).
  • Represent the company and department externally on relevant occasions as well as attendance of bid defense meetings.
  • Support and/or lead key regulatory, safety and clinical departmental initiatives.
  • Build relationships to existing and future clients.
  • Provide direction of the department in the hiring, mentoring, professional development and performance management of the staff.
  • Ensure execution of cross-functional and global corporate goals.
  • Lead clinical strategy through development of the study synopsis with identification and coordination with necessary resources and input from other departments (e.g., biostatistics, medical affairs, pharmacokinetics).
  • Lead regulatory/health authority meetings for clients.
  • Act as key point of contact for regulatory agencies/health authorities for clients.
  • Oversight of Regulatory submissions for early, late and approved products.
  • Prepare (write, review, edit) independently, regulatory documents for submission to regulatory agencies/health authorities.

Qualifications
  • Bachelor's or Master's degree with a scientific background and a minimum of 15 years applicable industry experience or equivalent combination of education and experience.
  • At least 8 years of management experience.
  • Excellent working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
  • Expert knowledge of CRO or consultancy business with emphasis in delivering with a high level of quality, on time, and on budget.


This job excludes Colorado applicants.

If you're passionate about bringing clinical trials to life, we encourage you to apply today!

Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.