Senior Project Manager, Regulatory Affairs

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Plan, prepare, and execute projects of high quality.

• Offer management and leadership for projects related to regulatory affairs.

• Collaborate with internal departments and company leadership.

• Engage externally with sponsors and vendors.

• Consolidate consulting activities and assignments across CMC, quality, regulatory, clinical, and business domains.

• Coordinate efforts with other teams.

⛳️ Requirements

• Bachelor's degree in life/health sciences or a related field, or equivalent experience is required.

• 6 to 8 years of pertinent regulatory experience within a Clinical Research Organization or Pharmaceutical Company.

• At least 3 years of experience in Project Management or as a functional team lead is mandatory.

• Other professional and/or educational experiences may count towards this minimum requirement, as assessed on an individual basis.

• Exceptional written and verbal communication skills, along with strong interpersonal abilities.

• Strong planning and organizational skills.

• Good understanding of the drug development process and regulatory requirements.

• Familiarity with International Conference on Harmonisation (ICH) guidelines and other relevant regulatory rules and guidelines.

• Proficient in English, both written and spoken.

• Capable of building effective project teams, inspiring others, delegating tasks, and making and executing decisions.

• Skilled at establishing and maintaining trust and confidence, while effectively communicating with clients, external vendors, and internal team members.

🏝️ Benefits

• Remote work opportunities.

• Flexible time off policies.

• Paid holidays.

• Medical insurance coverage.

• Tuition reimbursement options.

• Retirement plans.

• Eligible for bonuses.