Director, Regulatory Affairs

🔥 14 hours ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $195k - $223k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

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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

• Provide strategic and operational regulatory consulting for client companies • Advise clients strategically, focusing on early development through NDA/BLA • Independently prepare regulatory documentation, including US IND, NDA/BLA modules, ODD, Fast Track and other designations, and FDA advice requests • Interact scientifically with internal cross-functional teams • Serve as a client-facing and agency point of contact • Interact with clients and FDA and lead interactions with Health Authorities • Support internal business development and marketing activities

🎯 Requirements

• Bachelor’s degree in science, toxicology, pharmacology, engineering or related field • Advanced Scientific degree such as Master’s degree, Ph.D. or Pharm.D. preferred, with applied training relevant to clinical trials • 10 years of relevant experience working directly for a CRO/ Pharmaceutical Company • Minimum 5 years of experience leading regulatory development projects • Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines • Knowledge of medical terminology, clinical trials, and clinical research • Excellent written and oral communication skills, including grammatical and technical writing skills • Familiarity with moderately complex study designs and regulatory requirements for Phase I-IV clinical trials • In-depth knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies • Demonstrated technical and supervisory leadership of staff • Skilled in Microsoft Word and Microsoft Excel, with ability to learn new applications • Excellent interpersonal, communication, and organizational skills • Ability to work independently and in a team environment

🏖️ Benefits

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