Review, provide comments on, and prepare documents for submission to FDA and HAs including protocols, investigator brochures, nonclinical and CMC amendments, USPI, CCDS and other regulatory documents.
Lead teams on the preparation, review and finalization of DSURs.
Assist teams with the development, review, and finalization of briefing documents to FDA or health authorities, conduct meeting rehearsals, and participate in regulatory meetings.
Provide regulatory guidance and strategy to assigned project teams.
Lead working groups responsible for the development of regulatory submissions; interact with other team members to ensure timely preparation and receipt of information required for regulatory submissions.
For ex-US submissions, lead and prepare submissions including IMPDs, CTAs and amendments.
Understand and identify potential regulatory risks and implications for ongoing and new projects, be proactive in identifying solutions to mitigate the risks and work effectively with team members and senior management to resolve them.
Scientific background (minimum BS degree or equivalent in the life sciences) with at least five years of experience in regulatory affairs for senior manager and seven years of experience in regulatory affairs for AD.
Thorough understanding of current and evolving FDA, ICH and other appropriate regulations and guidance. Experience with EMA, NAs, PMDA and other ex-US HAs is desirable.
Experience with the preparation of INDs and amendments required and experience with NDAs/MAAs preferable.
Leadership and management skills with the ability to manage simultaneous priorities and changing deadlines.
Excellent oral and written communication skills.
Excellent planning, organizational and prioritizing skills.
Proficiency in the use of MS Word, PowerPoint; experience with Adobe Acrobat Professional; experience with electronic publishing systems.