Regulatory Affairs Specialist

Remote,

Join Our Team as a Regulatory Affairs Specialist!

Are you a seasoned regulatory professional with a passion for driving innovation in the pharmaceutical industry? We are seeking a talented and dedicated individual to join our team as a Regulatory Affairs Specialist. In this role, you will play a key role in providing strategic and technical regulatory guidance to our team

Responsibilities:

  • Provide strategic regulatory guidance to the diligence team
  • Develop and maintain in-depth regulatory knowledge of disease areas
  • Assess and make recommendations on regulatory matters
  • Identify and progress global regulatory strategies for our product portfolio
  • Ensure consistent approaches to Health Authorities across therapy areas
  • Monitor regulatory agency activities and assess their impact on programs

Top Technical Skills:

  • In-depth understanding of global regulatory requirements
  • Experience in regulatory due diligence activities
  • Ability to interpret regulations and guidelines
  • Proficiency in preparing major regulatory submissions
  • Direct experience in interfacing with regulatory authorities
  • Effective communication and organizational skills

Experience and Education:

  • Minimum Scientific Degree (BSc, MD, PhD, PharmD, MSc) or equivalent experience
  • Minimum 12 years of pharmaceutical/biotechnology industry experience
  • Demonstrated experience in drug development and regulatory affairs
  • Strong interpersonal skills and ability to lead multi-disciplinary teams

Join us in making a difference in the lives of patients worldwide. Apply today!

About SSi People:
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
 

Max. file size: 500 MB.
Subscribe to job alerts