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Soleno Therapeutics, Inc. · 1 day ago

Senior Associate, Regulatory Affairs

Redwood City, CA

Full-time

Onsite

Mid, Senior Level

$95K/yr - $130K/yr

2+ years exp

Soleno Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing novel therapeutics for rare diseases. The Senior Associate, Regulatory Affairs will support the regulatory team by implementing regulatory strategies for development programs from early phase through commercialization.

BiotechnologyMedicalPharmaceutical

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

Qualification

Regulatory AffairsUS regulations knowledgeECTD submissionsMS Office proficiencyDrug development processTeam playerAttention to detailCommunication skills

Required

A degree in a life science or closely related discipline with a graduate degree preferred

A minimum of 2 years of experience in pharmaceutical / biotechnology regulatory affairs or similar role

Proven proficiency in MS Word, Excel, Power Point, Visio, Adobe Acrobat

Experience with document formatting templates

Working knowledge of US regulations and relevant guidelines (e.g., FDA, ICH, etc.)

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