Senior Project Manager, Regulatory Affairs

Veristat; Milton (MA); Hybride; USD 128 000 - 144 000; Plein temps

Avantages offerts par ce poste

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Résumé du poste

Veristat is seeking a Senior Project Manager, Regulatory Affairs to provide leadership in planning, preparing, and executing high-quality regulatory projects. The role interfaces with internal departments, leadership, sponsors, and vendors, coordinating across CMC, quality, regulatory, clinical, and business areas.

The successful candidate will join a global team with decades of experience moving therapies toward patients.

Qualifications

• Bachelor’s degree in life/health sciences or related discipline, or equivalent required.
• 6 to 8 years of regulatory experience in a CRO/pharma, with a minimum of 3 years of Project Management or functional team lead experience.
• Excellent written and oral communication and interpersonal skills, as well as strong planning and organizational ability.
• Good working knowledge of the drug development process and regulatory requirements, including familiarity with ICH guidelines.
• Proficiency in English (written and verbal).
• Ability to build and maintain trust, communicate effectively with clients, vendors and internal teams.

Responsabilités

• Lead and coordinate regulatory projects across CMC, quality, regulatory, clinical, and business.
• Interface with sponsors, vendors, and internal leadership.
• Plan, prepare, and execute high-quality projects.
• Integrate consulting activities across all areas of consulting.

Connaissances

Project management

Communication skills

Regulatory affairs

Team leadership

Organizational skills

English proficiency

Formation

Bachelor’s degree in life/health sciences or related discipline

Description du poste

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.