Regulatory Affairs Manager Job at The Ritedose Corporation, United States

  • The Ritedose Corporation
  • United States

Job Description

Regulatory Affairs Manager

Hot Job

Fully Remote • The Ritedose Corporation

Overview

Salary Range $96,000.00 - $125,000.00 Salary/year Job Shift Day Education Level 4 Year Degree

Description

The Regulatory Affairs Manager is responsible for supporting development and execution of regulatory strategies for ANDA submissions as well as CDMO support for customer-led submissions (FDA and global). The Regulatory Affairs Manager will ensure compliance with regulatory requirements and manage lifecycle activities in alignment with the Director of Regulatory Affairs.

Responsibilities:

  • Provide critical support in writing and editing technical documents to support submissions for internal ANDA projects as well as customer-led global submissions.
  • Serve as primary RA contact on project teams to support product development.
  • Format, publish, and submit documentation to the FDA for initial and lifecycle submissions.
  • Respond to FDA queries and deficiencies.
  • Provide guidance to RA Associates and aid in development of team.
  • Develop and implement regulatory strategies for product development, registration, and maintenance across assigned markets.
  • Monitor and interpret new and evolving regulations and assess impact on company products.
  • Draft, review, and finalize product labeling for ANDA submissions, including structured product labeling.
  • Oversee adverse event reporting process and ensure compliance with reporting requirements.
  • Support due diligence activities, licensing, and partnerships.
Qualifications
  • Bachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related field
  • 5+ years regulatory affairs experience; FDA submission experience required, experience with device and/or drug/device combination products preferred
  • Highly detail-oriented and possess considerable problem-solving and organization skills
  • Ability to work on complex projects and take initiative with general direction and minimal guidance
  • Ability to be flexible with a change in priorities
  • Excellent written, verbal, and listening skills, must work well with others
  • Experience using an electronic document control system
  • Experience with eCTD publishing software preferred
  • Proficient with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat

Job Tags

Remote work, Flexible hours, Shift work

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