Senior Project Manager, Regulatory Affairs

Responsibilities

The Senior Project Manager provides leadership to plan, prepare, and execute high-quality regulatory projects while interfacing with internal departments, sponsors, and vendors. They integrate consulting activities across CMC, quality, regulatory, clinical, and business areas in coordination with other teams.

Requirements

Candidates must have a bachelor's degree in life or health sciences and 6 to 8 years of relevant regulatory experience in a clinical research or pharmaceutical environment. A minimum of 3 years of project management or functional team lead experience is required, along with strong knowledge of drug development and regulatory guidelines.

Skills

• Regulatory affairs
• Project management
• Clinical research
• Drug development
• ICH guidelines
• Leadership
• Communication
• Interpersonal skills
• Planning
• Organizational ability
• CMC
• Quality assurance
• Team building
• Decision making
• Delegation

Benefits

• Remote working
• Flexible time off
• Paid holidays
• Medical insurance
• Tuition reimbursement
• Retirement plans

About this role

Job Description:
Senior Project Manager, Regulatory Affairs

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.

Make an Impact at Veristat!

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
Learn more about our core values here!
What we offer:

The estimated hiring range for this role is $128 – 144K plus applicable bonus. This hiring range is specific to the USA and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.

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

What we look for:

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.

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

About Veristat

Research Services · 501-1,000 employees · headquartered in Southborough, Massachusetts