Regulatory Scientist/Senior Regulatory Scientist

About the Opportunity

In this Regulatory Scientist/Senior Regulatory Scientist role, responsibilities include:

(1) Regulatory Sciences:

• Write, review and assemble high-quality regulatory submissions, including but not limited to: New Drug Applications (NDAs)/Biologic License Applications (BLAs), Quality Modules of Marketing Authorization Applications (MAA), Investigational New Drug (IND/IMPD), Pre-IND briefing documents, Orphan Drug Designations (ODDs) applications & annual reports, and Pre-IND, EoP2, Pre-NDA briefing documents
• Agency interactions, correspondence, and meeting preparation
• 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.

(2) Chemistry, Manufacturing, and Controls (CMC):

• Lead/Participate in the definition and implementation of CMC regulatory strategies for the development and registration of innovative drugs.
• Provide advice on operational and technical CMC subjects (manufacturing, analytical development, validation, specification setting, stability, etc.).
• 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 CMC regulatory activities.
• Remain current with CMC EU and US trends and requirements.
• Manage CMC regulatory risks and potential based on global regulations and guidance.

(3) 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.

(4) 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

Requirements

The ideal candidate will possess the following qualifications:

• Must be local to our Cambridge office. A flexible hybrid work schedule will be provided.

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
• Prior experience directly interacting with the FDA/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
• Certification: RAC is a plus

Personal attributes and skills

• Strong writing and communication (written and verbal) skills.
• Strong attention to detail, organization/multitasking, project management (planning, scheduling, documentation, project control), and teamwork 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

Benefits

• Health Care Insurance plans (Medical/Dental/Vision)
• FSA and company-funded HRA plans
• Retirement Savings Plan (401k plan with company safe harbor matching contributions