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
