Regulatory Project Manager
Position: Regulatory Project Manager
- 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:
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.
- Equal Opportunity Employer
- All resumes are held in confidence
- Must be eligible to work in the US