Senior Regulatory Affairs Project Manager (Remote)

Veristat

Milton (MA)

Hybrid

USD 128,000 - 144,000

Full time

7 days ago
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Benefits offered by this job

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

Job summary

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.

Responsibilities

  • 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.

Skills

Project management
Communication skills
Regulatory affairs
Team leadership
Organizational skills
English proficiency

Education

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

Job description

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.

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