Senior Regulatory Affairs Manager

Senior Regulatory Affairs Manager

The Senior Regulatory Affairs Manager manages assigned regulatory and cross-functional projects; provides strategic and operational support to Veristat clients in regulatory decision-making processes, filings and maintenance of healthcare products and plays a key role in providing consultation to Veristat’s clients, in translating regulatory requirements into practical application to ensure the success of clinical trials and regulatory submissions. S/he will work with project teams, provide advice on regulatory agency interactions, manage agency communications, support the preparation of submissions, and create strong rapport with clients.

Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.

• 105+ approved therapies for marketing applications prepared by Veristat
• 480+ oncology projects in the past 5 years
• 350+ rare disease projects delivered in the past 5 years
• Flexible, inclusive culture — 70% remote workforce, 66% women-led teams

• Benefits vary by location and may include:
  • Remote working
  • Flexible time off
  • Paid holidays
  • Medical insurance
  • Tuition reimbursement
  • Retirement plans

• Bachelor’s degree in a related field required. Advanced scientific degree (i.e. PhD or Master’s degree) preferred.
• 6 - 8 years of regulatory affairs experience in a clinical research organization and/or pharmaceutical setting (or demonstrated ability to function at this level), with a proven track record of global regulatory submissions
• As Senior Manager Regulatory Affairs CMC: familiar with manufacturing, specifications, analytical testing and overall regulatory CMC requirements
• Thorough knowledge of International Conference on Harmonisation (ICH) guidelines and regulatory guidelines in the relevant territories as well as drug development, clinical trials, and clinical research
• Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with drug development, agency interactions, study designs and regulatory requirements that apply to clinical trials are required
• Demonstrated ability to develop and foster positive client relationships.
• Demonstrated ability to lead by example and demonstrated skill for technical leadership of staff.
• Skilled in use of computer software, including Microsoft Word and Microsoft Excel, and ability to learn new applications.
• Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.

Automated Decision Making:
All applicants are reviewed by a member of the Veristat Talent Acquisition team;
Veristat does not utilize an automated decision-making process.

Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.