Job Title: Senior Regulatory Associate

Department: Regulatory Affairs

Location: Menlo Park, US

Overview of Role:

The Senior Regulatory Associate role will be working with regulatory operations as well as regulatory affairs on submission preparation to global regulatory authorities. Specifically, this role will work closely with the Regulatory Operations Manager and the Regulatory Leads to support day-to-day activities.

Role and Responsibilities:

  • Collaborate with cross-functional teams to prepare regulatory submissions, manage content and development process of documents to submit to global health authorities.

  • Compile high-quality electronic regulatory dossiers (eCTD) according to health authority requirements and guidance, including publishing and submission of dossiers

  • Independently perform document formatting on MS Word documents, converting documents to PDF, and formatting PDFs to comply with FDA and other health authority specifications, including troubleshooting issues and identifying solutions.

  • Perform quality control checks and working with team to address findings

  • Prepare and manage routine IND life-cycle maintenance submissions that are high quality, accurate, and regulatory compliant, in accordance with timelines.

  • Identify issues during document formatting and/or publishing and liaising with responsible person to resolve issues

  • Draft 1571 and cover letters to FDA as assigned

  • Adhere to required submission timelines, health authority publishing specifications, and internal working practices

  • Archive of FDA correspondences, acknowledgements, final outputs

  • Review certain study-related documents, e.g., IP-release packages for clinical sites,

  • Assist with administrative aspects related to regulatory activities, eg, new/updated investigator submissions, 1572s/IRB waiver requests

  • Provide regulatory support as needed

  • All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

  • Bachelor’s degree in life sciences or a related discipline required

  • A minimum of 3+ years of industry experience, including preparation, publishing, and submissions for INDs and CTAs

  • Must have experience with document formatting on MS Word documents, converting documents to PDF, and formatting PDFs to comply with FDA and other health authority specifications

  • Experience with electronic publishing tools for regulatory submissions (experience with publishing software)

  • Experience in using MS Office Suite (Word, SharePoint, EndNote), Adobe Acrobat and ISIToolBox, and other relevant tools

  • Knowledge of eCTD submission requirements and lifecycle management of eCTD submissions

  • Knowledge of applicable FDA and ICH guidelines related to regulatory submissions, clinical trials, and marketing applications

  • Excellent time and project management skills, attention to detail, accuracy, and confidentiality

  • Clear and concise oral and written communication skills, ability to work on teams

  • Critical thinking, problem solving, ability to work independently.

  • Strong computer and database skills

The pay range for this role is $95,000-$110,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with up to a 15% discount up to the federal limit, flexible spending account among other benefits.

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