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Regulatory Affairs Manager

The Ritedose Corporation

Columbia, SCFull-timePosted 6mo agoSeen in employer's feed 5 days ago

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At a glance

Compensation
No compensation found
Location
Columbia, SC
Schedule
Full-time
Work Authorization
Not specified

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Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

The Ritedose Corporation is hiring a Regulatory Affairs Manager. The Regulatory Affairs Manager supports development and execution of regulatory strategies for ANDA submissions and CDMO customer‑led submissions, ensures compliance with FDA and global requirements, and manages lifecycle activities in alignment with the Director of Regulatory Affairs while providing guidance to associates and overseeing adverse event reporting.

Key focus areas include Provide critical support in writing and editing technical documents for internal ANDA projects and customer‑led global submissions., Serve as primary regulatory affairs contact on project teams to support product development., and Format, publish, and submit documentation to the FDA for initial and lifecycle submissions..

Successful candidates bring Bachelor's In Science (Biology, Chemistry, Engineering, Pharmaceutical Sciences), 5+ Years Regulatory Affairs, and FDA Submission Experience. Important skills include Regulatory Strategies, ANDA Submissions, CDMO Support, Regulatory Compliance, Lifecycle Activities Management, and Technical Document Writing. Preferred (not required): Problem Solving, Organization, Communication, and Electronic Document Control System.

Skills & qualifications

RequiredNice to have

Skills

Problem SolvingOrganizationCommunicationElectronic Document Control SystemeCTD Publishing SoftwareMicrosoft WordMicrosoft ExcelPowerPointAdobe AcrobatRegulatory StrategiesANDA SubmissionsCDMO SupportRegulatory ComplianceLifecycle Activities ManagementTechnical Document WritingTechnical Document EditingProduct Development SupportDocumentation PublishingDocumentation Submission to FDAResponding to FDA QueriesResponding to FDA DeficienciesMonitoring RegulationsInterpreting RegulationsAssessing Regulatory ImpactProduct Labeling DraftingProduct Labeling ReviewProduct Labeling FinalizationStructured Product LabelingAdverse Event Reporting OversightDue Diligence SupportLicensing SupportPartnerships SupportDetail-OrientedOrganization SkillsInitiativeAdaptabilityListening SkillsCollaborationExcel

Qualifications

Bachelor of Science in BiologyBachelor of Science in ChemistryBachelor of Science in EngineeringBachelor of Science in Pharmaceutical SciencesBachelor of Science in Related Field5+ Years Regulatory Affairs ExperienceFDA Submission ExperienceDevice Experience

Full job 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

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