Regulatory Affairs Manager
Roche
Senior Director, Regulatory Affairs
eGenesis, Inc.
full-time
Posted on:
Origin: • 🇺🇸 United States • Massachusetts
Visit company websiteJob Level
Senior
About the role
- Lead the eGenesis team to create regulatory strategies for each transplant organ program and successfully manage complex issues which have significant impact on the business
- Lead definition of regulatory milestones and ensure that the company remains on track to support achievement of those milestones
- Lead and manage consultants and CROs who are charged to support regulatory activities
- Manage all activities pertaining to interactions and communications with FDA and other regulatory agencies in the United States, and other global agencies as needed
- Provide regulatory oversight in the preparation and review of draft and final submissions/reports
- Work cross-functionally to anticipate the impact of current and emerging trends, identify potential opportunities and threats, and advise departments and project teams accordingly
- Participate in and sometimes lead interactions with FDA and other regulatory authorities for assigned projects to ensure acceptance, review, and approval of INDs, INADs, NADAs, BLAs, amendments
- Host FDA/third party regulatory audits and ensure follow up on findings/observations
- Represent eGenesis at company and industry committees, conferences, and organizations
- Ability to work independently while fostering collaboration of team members in other functions
Requirements
- Bachelor’s degree with 10+ years of experience in Regulatory Affairs (advanced degree preferred)
- Experience in the successful development and registration of therapeutics
- Requirements for clinical protocol development, study/trial conduct, data collection, and data analysis
- Knowledge of manufacturing requirements
- Understanding of quality assurance and GxP requirements
- Preparation of meeting requests and submissions (e.g., VIP, INTERACT, pre-IND, IND, NADA, BLA)
- Negotiation with and presenting to regulatory agencies
- Hands-on, roll-up-your-sleeves approach with the ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
