Regulatory Advisor - Biotech/Pharma

Company: Planet Pharma
Location: San Francisco
Posted on: September 17, 2020

Job Description:

Regulatory AdvisorJob DescriptionThe Regulatory Advisor is responsible for creating regulatory strategies, leading global health agency filings, and managing FDA communications on behalf of Pearl clients for devices and biopharmaceutical products. This role has the day to day responsibility for leading client projects to support product development, submissions, and post marketing activities.--Responsibilities include:Develop regulatory strategies for global submissionsLead regulatory submissions: IND, IDE, NDA, BLA, PMA, 510k, etc. and their global counterparts including CE Marks.Manage FDA and other global health authority face-face communications and via all other communication channelsWrite regulatory documents - for paper and eSubmissionLead cross functional teams across clinical, CMC, device engineering, quality, etc., in gathering and authoring required information for submissionReports directly to Director of Quality/Regulatory--Training/Experience Requirements:At least 10 years drug OR device regulatory experience.RAC certification preferredBachelor's degree required--SkillsStrong technical background requiredSome experience in quality assurance roles or auditing preferredTrack record of leading regulatory strategy and filings for bio-pharma and/or device industryBoth drug and device experience a plusMix of large sponsor company and small startup experience a plusGlobal filing experience preferredAbility to work autonomouslyExceptional communication skills, both verbal and written

Keywords: Planet Pharma, San Francisco , Regulatory Advisor - Biotech/Pharma, Other , San Francisco, California