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Senior Regulatory Submissions, Manager

2 weeks, 6 days ago
United States
Full-time
Senior
Program Manager
Project and Program Management
Apply Now
Praxis Medicines

Praxis Medicines

Praxis Medicines is focused on translating genetic insights into the development of precision therapies aimed at treating central nervous system disorders characterized by neuronal imbalance, with a commitment to making significant advancements in neur...

Pharmaceuticals
51-250
View All Jobs 10

Description

  • Ensure continuous, compliant, and timely regulatory submissions to U.S. and international agencies.
  • Create and manage submission content plans with Regulatory Affairs, CMC leads, cross-functional colleagues, and global vendors.
  • Plan and coordinate regulatory submissions from initiation through approval and dispatch, including IND, IMPD, NDA, MAA, and agency responses.
  • Publish, validate, and transmit eCTD submissions to the gateway.
  • Track regulatory commitments for assigned products.
  • Schedule and coordinate submission deliverables with contributing departments.
  • Communicate with functional authors to obtain submission documents on time.
  • Manage the publication and submission of regulatory documents in eCTD format and, when required, in paper format.
  • Oversee the writing, review, implementation, and continuous improvement of standards, templates, and procedures for regulatory documentation.
  • Maintain best practices aligned with evolving FDA and international electronic submission guidelines.
  • Serve as a point of contact for electronic document management systems and publishing tools, including issue identification and resolution.

Requirements

  • Bachelor’s degree in a scientific or relevant technical discipline preferred.
  • 7+ years of experience in the pharmaceutical or biotech industry.
  • Basic regulatory operations experience managing the creation and submission of IND, NDA, or BLA filings.
  • Experience with Microsoft Word, Adobe Acrobat, Smartsheet, electronic publishing software, and electronic document management systems required.
  • Experience with Veeva RIM, Veeva Submissions, and Veeva Archive preferred.
  • Experience with Veeva Publishing preferred.
  • Current knowledge of eCTD and submission publishing tools, including eCTD building tools.
  • Experience publishing, validating, and submitting in full eCTD format.
  • Ability to work in a biotech start-up, fast-paced, innovative, and dynamic environment.
  • Ability to adhere to strict project timelines and budgets and communicate impacts and changes to teams and management.

Benefits

  • Remote work with flexibility and willingness to travel as needed.
  • 99% employer-paid medical, dental, and vision premiums.
  • Company-paid life insurance, AD&D, and disability benefits.
  • Voluntary plans to customize coverage.
  • Dollar-for-dollar 401(k) match up to 6% on eligible contributions.
  • Long-term stock incentives and ESPP.
  • Discretionary quarterly bonus.
  • Generous PTO, paid holidays, and company-wide shutdowns.
  • Extremely flexible wellness benefit.
  • Annualized base salary of $120,000 to $140,000 USD.

Interested in this position?

Apply directly on the company website

Apply Now

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