What are the responsibilities and job description for the Senior Director Regulatory Affairs position at Aura BioSearch?
Senior Director of Regulatory Affairs
We have partnered with a growing biotech company in San Francisco, CA, to help them find an experienced Senior Director of Regulatory Affairs to join their expanding team.
This pivotal role will involve developing and implementing regulatory strategies to meet global requirements while aligning with business objectives. The Senior Director will act as the key point of contact for regulatory operations and submissions, collaborating with both internal and external teams.
This is a full-time, permanent position with a preference for candidates who can regularly work from the San Francisco office.
Key Responsibilities :
- Lead cross-functional teams in the development and execution of long-term regulatory strategies that meet global regulatory requirements and align with corporate goals.
- Provide ongoing oversight and guidance on global regulatory activities, risk assessments, and mitigation strategies.
- Oversee regulatory operations, leading global submissions such as INDs / CTAs and NDAs / BLAs, and managing correspondence with agencies like the FDA and EMA.
- Ensure the timely and accurate submission of regulatory filings, including clinical trial data, preclinical studies, and manufacturing details.
- Manage internal and external teams, vendors, consultants, and experts to ensure the right strategies and progress for regulatory activities.
- Develop and implement policies and procedures for regulatory activities, maintaining organized and accessible documentation.
- Ensure compliance with regulatory standards (e.g., GCP, GMP, GLP).
- Proactively identify and resolve risks, bottlenecks, and potential issues in regulatory-related activities.
- Regularly assess resources to meet approved regulatory initiatives and stay updated on evolving regulatory guidelines and industry best practices.
- Provide regular updates to cross-functional teams and leadership to ensure alignment and tracking of initiatives.
Qualifications :
If you’re looking for a dynamic opportunity in a growing company and meet the qualifications above, we’d love to hear from you! Feel free to reach out or apply directly.
