Senior Project Manager, Regulatory Affairs

🔥 0 minutes ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

💵 $128k - $144k / year

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

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Veristat

WebsiteLinkedInAll Job Openings

501 - 1000 employees

💼 Consulting

🏥 Healthcare

💊 Pharmaceuticals

💰 Private equity on 2021-05

Consulting • Healthcare • Pharmaceuticals

Veristat is a clinical development services company that provides end-to-end, regulatory-focused support for biopharmaceutical and medical device sponsors. The firm offers full-service clinical trial planning and conduct, regulatory affairs and submission support (including NDA/MAA and interactions with agencies like PMDA), statistical and biometrics services, medical writing, pharmacovigilance, and project management for complex therapeutic areas such as oncology, rare diseases, neurology, biologics, and cell & gene therapies. Veristat operates as a B2B partner to biotech and pharmaceutical organizations to reduce development risk and accelerate regulatory approval.

📋 Description

• Plan, prepare, and execute high quality projects • Provide management and leadership for regulatory affairs projects • Interface with internal departments and company leadership • Interface externally with sponsors and vendors • Integrate consulting activities and assignments across CMC, quality, regulatory, clinical, and business areas • Coordinate work with other teams

🎯 Requirements

• 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 • 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 • Strong planning and organizational ability • Good working knowledge of drug development process and regulatory requirements • Familiarity with International Conference on Harmonisation (ICH) guidelines and other applicable regulatory rules and guidelines • Proficiency in English (written and verbal) • 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

🏖️ Benefits

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