The Senior Manager/Associate Director, Regulatory Affairs integrates and applies knowledge of US and ex-US regulatory guidelines to AVROBIO’s pipeline development programs. Ensures global strategies are successfully implemented and executed across AVROBIO’s portfolios. Interfaces cross-functionally both within AVROBIO and external service providers/partners. Participates as a member of the project program development team(s) to build awareness of Regulatory Authority requirements and timing for submissions. Demonstrates leadership and has comprehensive understanding of global regulations and guidelines to address and overcome challenges that arise during development and commercialization. Collaborates with functional groups to plan, author, compile and submit high-quality original applications, amendments, supplements and responses to inquiries from FDA and international Health Authorities. Successfully communicates and negotiates directly and indirectly with international Health Authorities as necessary.
1. Contributes/Develops /Implements global regulatory strategies including scenarios for the earliest regulatory approvals possible as well as an assessment of risk for each of the various scenario, identifies, monitors and resolves regulatory issues and reports progress.
2. Leads regulatory submission activities and reviews regulatory documents prior to submission to ensure overall quality, compliance and timeliness with minimal supervision.
3. Coordinates cross-functional teams in the R&D organization to review and approve submission document deliverables and ensures the submission documents that are in high-quality.
4. Collects and analyzes regulatory intelligence for assigned projects and communicates assessments with advice on regulatory significance and options.
5. Leads/supports Health Authority interactions including briefing document preparation, coordination of meeting, preparations with subject matter experts, and documentation and archiving of minutes.
6. Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues.
- BS degree in a science related field and minimum 8 years Regulatory Affairs experience in the pharmaceutical or biotechnology industry in positions of increasing strategic and leadership; advanced degree preferred (PhD, MS, PharmD, or equivalent)
- Experience in development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document;
- Experience interacting with the FDA and ex-US health authorities and working knowledge of relevant drug laws regulations, and guidance’s/guidelines;
- Demonstrated matrix leadership skills and the ability to work effectively in a matrix team across multiple disciplines;
- Ability to work in a fast-paced, start-up environment; strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
Click here for LinkedIn Easy Apply: Senior Manager/Associate Director, Regulatory Affairs
AVROBIO, Inc is an EEO employer
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.