[Remote] Senior Project Manager, Regulatory Affairs

Note: The job is a remote job and is open to candidates in USA. Veristat is hiring a Senior Project Manager, Regulatory Affairs to plan, prepare, and execute high-quality projects. The role leads coordination across consulting areas, internal teams, sponsors, and vendors.

Responsibilities

• The Senior Project Manager, Regulatory Affairs provides management and leadership to plan, prepare, and execute high quality projects
• S/he interfaces with internal departments and company leadership, and externally with sponsors and vendors
• The Senior Project Manager, Regulatory Affairs will integrate consulting activities and assignments across all areas of consulting conducted (CMC, quality, regulatory, clinical and business) in coordination with other teams

Skills

• Bachelor's degree in life/health sciences or related discipline, or equivalent required
• 6 to 8 years of relevant Regulatory experience in a Clinical Research Organization/Pharmaceutical Company, with a minimum of 3 years of Project Management or functional team lead experience required
• Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case by case basis
• Excellent written and oral communication and interpersonal skills, as well as strong planning and organizational ability are required
• Good working knowledge of drug development process and regulatory requirements, including familiarity with International Conference on Harmonisation (ICH) guidelines and other applicable regulatory rules and guidelines
• Proficiency in English (written and verbal)
• Action-oriented and resilient in a fast-paced environment and will have the ability to build effective project teams, motivate others, delegate, and make and implement decisions
• Ability to build and maintain trust and confidence and communicate effectively with client, external vendors, and internal team members

Benefits

• Applicable bonus
• Benefits vary by location and may include remote working
• Benefits vary by location and may include flexible time off
• Benefits vary by location and may include paid holidays
• Benefits vary by location and may include medical insurance
• Benefits vary by location and may include tuition reimbursement
• Benefits vary by location and may include retirement plans

Company Overview