Title: Senior Director, Regulatory Affairs REMOTE
Summary: Focused on autoimmune disease, this rapidly growing clinical-stage biopharmaceutical company is looking to bring on an expert in regulatory affairs to lead their team. Motivated to help normalize the lives of patients with autoimmune disease, the team is looking for a leader who has in depth experience with biologics and regulatory affairs. This is a unique opportunity to make a direct impact and shape the regulatory team of a clinical stage biotech.
The Senior Director, Regulatory Affairs will be responsible for:
- Developing and leading regulatory strategy and implementing regulatory strategy cross-functionally to maximize success and mitigate risks
- Lead interactions with FDA and other Health Authorities while communicating with internal leadership and stakeholders to track project updates and timelines.
- Hands-on cross-functional leadership in the planning, preparation, coordination and submission of regulatory documents for global health authorities
- Initiate the development of policies and procedures in alignment with updated global regulatory requirements and corporate objectives
The Senior Director, Regulatory Affairs should have the following qualifications:
- 10+ years of experience in biopharmaceutical industry, 7+ years of Regulatory Affairs experience
- BS Degree required, MS or PhD preferred
- In depth experience with biologics and orphan/rare disease product development
- In depth knowledge of health authority guidelines and regulatory submissions (IND, CTA, NDA, BLA, MAA)
- Direct experience leading interactions with the FDA and global health authorities
- Leadership experience in developing and implementing regulatory strategy, leading regulatory teams with direct reports, and working cross-functionally
- Driven and self-motivated personality that thrives in a collaborative, team oriented environment.
If you are interested in the Senior Director, Regulatory Affairs role, then please don't wait to apply.