Regulatory Project Manager

Position:        Regulatory Project Manager 

Responsibilities include:

  • Coordinate with US and international clients to provide regulatory strategy, guidance, and submission support
    • Plan, write and prepare documents for submission to FDA and international Health Authorities supporting clients’ investigational and marketing applications.
    • Author and compile regulatory documents to support INDs, NDAs, BLAs, ANDAs and DMFs.
  • Monitor, prioritize, and supervise multiple projects at different stages of development
    • Proactively communicate with clients throughout the project to establish strategy and timelines, agree on content and format of the submission, review/assess submission documents, including gap assessment.
    • Represent companies as their designated Regulatory/US Agent.
  • Coordinate and manage all eDRLS submissions to ensure compliance
    • Manage, review, submit and maintain Facility GDUFA Self Identification, PDUFA updates, Labeler Code Requests, Establishment Registrations and Drug Listings.
    • Monitor DAILYMED and Establishment Registration database and confirm all submissions are listed correctly.
    • Communicate with FDA’ eDRLS and SPL teams as needed.
  • Work with senior staff to help formulate and execute regulatory strategy as well as author submissions to support all activities related to FDA meetings.
  • Ensure compliance with regulations and applicable guidelines.

The ideal candidate will possess the following qualifications:

  • Experience

    Knowledge of regulatory sciences as demonstrated through a combination of work experience and academic background:

    • Prior professional experience in pharma, bio tech, or medical devices companies.
    • Prior experience with regulatory submissions and interactions with the FDA or other Health Authorities.
    • Prior experience with eDRLS submissions.
    • Knowledge and experience with eCTD.
    • Interpret and apply regulations as they apply to specific project issues: 21 CFR, FDA, ICH, or other regulatory agency guidance requirements.
    • Experience in a consulting environment is a plus.
    • BS/BA in Regulatory Sciences or Life Sciences. RAC and/or MS/Ph.D. are a plus.

  • Personal attributes and skills

    • Project management skills: research, planning, scheduling, documentation, and project control.
    • Strong attention-to-detail, organization/multitasking, teamwork, and communication (verbal/written) skills.
    • Consulting skills: influencing, advising, facilitating, diplomacy, critical thinking, adaptable, and presenting.
    • Problem-solving abilities and a self-starter.
    • Professional and courteous work demeanor in interactions 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.
    • Maintain company values 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