Regulatory Scientist/Senior Regulatory Scientist

Company : VCLS

Country: United States

Location : Cambridge, Massachusetts

Post: Fri, 24 Mar 2023 05:20:13 GMT

Expires: Fri, 21 Apr 2023 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

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

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

Paid Time Off (Vacation/Sick/Company Holidays)

Group Term Life/AD&D,Short Term Disability, and Long Term Disability insurance

Training and Development, including company programs, external training, LinkedIn Learning, and professional memberships

Hybrid work schedule: Work From Home and in-office (free snacks)