An extremely exciting Biotech based in the heart of the Bay Area is looking for a superstar to step in and head their Regulatory department (Assoc. Director/Director/Sr. Director). The focus of their research and development targets small molecule drugs to improve auto immunity as well as utilizing their understanding of protein homeostasis and applying it to their very novel therapeutic in the Oncology space. Their work on protein regulation have produced some ground-breaking findings and has allowed them to expand their reach in multiple indications. Their clinical trials have been extremely successful, and they have been recently granted a large amount of funding.
This position will be responsible for global regulatory submissions and responses as well as regulatory management and strategies. The head of Regulatory affairs will also be collaborating with development team members, emphasize proper strategic and operational planning, while also being responsible for all other aspects of regulatory affairs. This position also has the option to work remote!
- Lead Regulatory Affairs activities while emphasizing proper Global Regulatory Strategy.
- Be involved in the preparation, review, and submission of documents to the FDA and other regulatory boards.
- Collaborate with other developmental teams to meet project deadlines; both internal and external while providing regulatory guidance.
- Be the primary point of contact for health authorities and regulatory consultants and manage regulatory meetings.
- Represent the Regulatory Affairs at cross functional submissions as well as study management team meetings.
- Support any pharmaco-vigilance related regulatory functions
- Team up with medical and technical writers to ensure proper document preparation timelines and communicate expectations with team members to allow timely reviews, achieve milestones, and document deliverables
- S. in Life Sciences, Chemistry, Biology, or related field. (Advanced degree is preferred)
- Regulatory Affairs Certification (RAC) is preferred.
- 5+ years of hands-on Regulatory experience in successful submissions of IND and IMPD as well as submissions of NDA/MAA is highly preferred.
- Knowledge of eCTD format and structure.
- Familiarity of GCP and GMP regulations.
- Strong strategic and analytical thinking skills, detail-oriented, and strong written/verbal communication skills.
- Demonstrate expertise as a regulatory liaison and understanding of global regulations, processes, and developmental issues.
- High level of computer skills particularly; Microsoft Office Suite, MS Project, and Adobe Acrobat.
- Competitive base salary
- Flexible PTO option
- Option to work Remote!
If this sounds like you, don't hesitate to reach out now!