Voisin Consulting Life Sciences job icon
Job

Regulatory Scientist | Drugs and Biologics | USA

USA | Cambridge, MA

About the Opportunity:

In this junior to mid-level Regulatory Scientist | Drugs and Biologics role, responsibilities include:

Write, review, and assemble high-quality regulatory submissions, including but not limited to

  • Orphan Drug Designations (ODDs): applications & annual reports
  • Preparation of IND modules
  • Pre-IND, EoP2, Pre-NDA briefing documents
  • Fast Track & Breakthrough Therapy Designation applications
  • Pediatric Study Plans (PSPs)
  • New Drug Applications (NDAs)/Biologic License Applications (BLAs)
  • Post-approval changes
  • FDA Interactions and Correspondence

Regulatory Sciences

  • Lead/Participate in the definition and implementation of regulatory strategies for the development and registration of innovative drugs and biologics.
  • Provide support for the preparation of Agency meetings (EU and US).
  • Participate in due diligence/gap analysis.
  • Direct interactions with global regulatory authorities; lead meetings and support regulatory activities.
  • Remain current with EU and US regulatory trends and requirements. Manage regulatory risks and potential based on global regulations and guidance.

Project Management

  • As a project team member, execute the prescribed activities for client projects, adhering to strategy, timelines, and milestones.
  • Project coordination and keeping track of timelines/deliverables using project management tools.
  • Timely internal and external communications and updates.

Knowledge Management

  • Perform background research and coordinate scientific, technical, and regulatory surveillance to be performed related to the Project
  • Contribute to the knowledge sharing within VCLS

The ideal candidate will possess the following qualifications (only candidates that meet the following criteria will be considered):

Experience

  • Knowledge of Regulatory Sciences as demonstrated through a combination of work experience and academic background.
  • Prior experience in pharma, biotech, or related life sciences industry
  • Prior experience with regulatory submissions and interactions with the FDA and other regulatory agencies preferred
  • Direct interactions with the Health Authorities is a plus
  • Good understanding of the drug development process
  • Experience in a consulting environment is a plus
  • BS/BA in Regulatory Affairs or Life Sciences. MS/MA and Ph.D. are a plus.

Personal attributes and skills

  • Strong attention-to-detail, organization/multitasking, project management (planning, scheduling, documentation, project control), teamwork, and communication (written and verbal) skills.
  • Consulting skills: influencing, advising, facilitating, diplomacy, critical thinking, adaptable, and presenting
  • Problem-solving abilities and a self-starter.
  • Professional and courteous work demeanor. A relationship builder with colleagues, clients, and regulatory authorities.
  • Ability to work under deadlines to meet project timelines, including the ability to modify work schedule when needed.
  • Computer skills including Windows, MS Office (Outlook, Word, Excel, PowerPoint, SharePoint), and Adobe Acrobat.
  • Maintains company values (People, Innovation, Passion, Excellence) and demands the highest standards of conduct from self and others.

Additional Information

  • Equal Opportunity Employer
  • All resumes are held in confidence
  • Must be eligible to work in the US