Senior Associate, Regulatory Affairs

About This Role

The Senior Associate, Regulatory Affairs supports the senior Regulatory team members in implementing regulatory strategies for Soleno’s development programs. This role involves preparing routine submissions, coordinating documentation with cross-functional teams, and performing regulatory research.

Responsibilities

• Prepare routine 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
• 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 to support their completeness and conformance with relevant regulations and guidance

Requirements

• Degree in a life science or closely related discipline
• Minimum of 2 years of experience in pharmaceutical / biotechnology regulatory affairs or similar role
• Proficiency in MS Word, Excel, Power Point, Visio, Adobe Acrobat
• Experience with document formatting templates
• Working knowledge of US regulations and relevant guidelines (FDA, ICH)
• 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

Qualifications

• A degree in a life science or closely related discipline with a graduate degree preferred
• Minimum of 2 years of experience in pharmaceutical / biotechnology regulatory affairs or similar role

Nice to Have

• Graduate degree
• Experience in a small company

Skills

* Required skills