Senior Associate, Regulatory Affairs

Soleno Therapeutics, Inc. • Redwood City, CA

1d • $95,000 - $130,000

About The Position

The Senior Associate, Regulatory Affairs reports to a Senior Director, Regulatory Affairs and will support the senior Regulatory team members. We are seeking a highly motivated and enthusiastic individual to continue their growth in regulatory affairs by supporting the implementation of regulatory strategies for Soleno’s development programs from early phase through commercialization. The Senior Associate, Regulatory Affairs will be based at our headquarters in Redwood City, CA.

Requirements

• A degree in a life science or closely related discipline with a graduate degree preferred and a minimum of 2 years of experience in pharmaceutical / biotechnology regulatory affairs or similar role. Experience in a small company is preferred.
• Proven proficiency in MS Word, Excel, Power Point, Visio, Adobe Acrobat. Must have experience with document formatting templates.
• Working knowledge of US regulations and relevant guidelines (e.g., FDA, ICH, etc.) and knowledge of the drug development process.
• Experience with preparation of CTA and IND submissions in eCTD format in at least one country.
• Proficiency in reviewing electronic submissions prior to submission by third-party publisher.
• Must be able to work independently and as a team player.
• Must be able to manage multiple concurrent projects, adapt to changing priorities across project teams, and complete submissions in alignment with project timelines.
• Must be accustomed to working in a fast-paced environment.
• Excellent verbal, written, negotiation and interpersonal skills are required. Must be articulate and able to communicate effectively both orally and in writing with employees at all levels of the global organization and external audiences.
• Must have a high level of attention to detail.

Responsibilities

• Prepare routine (e.g., new investigator information, etc.) submissions to health authorities in accordance with applicable regulations and guidelines.
• Participate in the preparation, review, and / or finalization of non-routine amendments to INDs and clinical trial applications.
• Collaborate with cross-functional teams to coordinate and facilitate delivery of submission documentation in accordance with pre-specified timelines.
• Perform regulatory research and assessments to inform global regulatory plans.
• Support preparation of responses to health authority requests.
• Support regulatory tracking, archival, and information management activities.
• Participate in the review of critical documents such as protocols, patient information sheets / informed consent forms, Investigator’s Brochures, Clinical Study Reports, DSURs, etc. to support their completeness and conformance with relevant regulations and guidance (e.g. ICH, FDA, EMA, etc.) prior to submission.
• Additional activities as requested.
• Work is performed under direction of a Senior Regulatory Affairs professional.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees