Senior Project Manager, Regulatory Affairs

Veristat; Oklahoma City (OK); A distancia; USD 128.000 - 144.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Descripción de la vacante

Veristat in the United States is seeking a Senior Project Manager, Regulatory Affairs to lead planning, preparation, and execution of high-quality regulatory projects. You will coordinate with internal departments, company leadership, sponsors, and vendors to align activities across CMC, quality, regulatory, clinical and business teams.

This remote-friendly role offers a US hiring range of $128k–$144k plus bonus.

Formación

• 6 to 8 years of regulatory experience in a CRO/pharma environment, with broad exposure across regulatory activities.
• Minimum of 3 years of project management or functional team leadership experience.
• Excellent written and oral communication and organizational skills.
• Good working knowledge of drug development process and regulatory requirements, including familiarity with ICH guidelines.

Responsabilidades

• Provide leadership to plan, prepare, and execute high-quality regulatory projects.
• Interface with internal departments, company leadership, sponsors, and external vendors.
• Integrate consulting activities across CMC, quality, regulatory, clinical and business areas.
• Ensure projects align with regulatory requirements and timelines.

Conocimientos

English proficiency

Project management

Regulatory affairs

Communication skills

Leadership

Educación

Bachelor’s degree in life/health sciences

Descripción del empleo

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

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.

• 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.

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