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Regulatory Affaris Manager/Director (Orange County, CA)

Snap Staffing - Brea, CA

Regulatory Affairs Manager/Director (Orange County, CA)

SNAPSHOT!

Are you looking for an exciting career opportunity with a technology-based special pharmaceutical company focused on the development and commercialization of therapeutic injectable drugs? THEN READ ON! Our client has a full array of expertise, including advanced scientific research in the area of drug delivery systems, process development, patent analysis, and regulatory compliance!

Immediate need for a Regulatory Affairs Manager/Director in Orange County, CA who possess:

  • Strong foundation in regulatory strategy, documentation, scientific concepts and regulatory frameworks.
  • Experience in regulatory submission (IND/ANDA/NDAs) and interaction with FDA and other regulatory agencies.
  • Proven ability to coordinate a variety of regulatory documents (quality, preclinical and clinical) in collaboration with other subject matter experts.
  • Electronic document management systems literacy and electronic submission experience in eCTD format.
  • Experience in regulatory operations, including authoring, formatting, publishing, submitting and archiving through document lifecycle.
  • Comprehensive knowledge in regulatory requirements including ICH, FDA, GXPs and other applicable industry standards.
  • Computer skills and working knowledge of Microsoft Office (Word, Excel, Powerpoint), Internet Explorer and Adobe Acrobat, etc.
  • Results and detailed orientated.
  • Basic project management skills.
  • Excellent written and oral skills.
  • Excellent organizational skills and ability to manage multiple projects and priorities.
  • Work well under deadlines.

Key responsibilities include:

  • Oversee all regulatory matters related to the Company’s pharmaceutical business in the US and provide guidance in regulatory discussions on ex-US matters.
  • Manage regulatory issues related to audits, regulatory agency inspections, product recalls.
  • Provide guidance with the development and implementation of clinical trial protocols.
  • Prepare and review dossiers and submission packages for regulatory agencies, e.g., IND/ANDA/NDA.
  • Prepare and oversee filing of all communications with regulatory authorities.
  • Assess the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable regulations and review processes and documentation on a regular basis.
  • Monitor the progress of the regulatory authority review process through appropriate communication.
  • Provide regulatory information and guidance for proposed product claims/labeling.
  • Assure post-marketing regulatory requirements are met, including pharmacovigilance.
  • Liaise with internal functions such as Manufacturing, R&D, and Clinical Operations to obtain necessary information and documents required for regulatory submissions.
  • Work with subject matter experts to create and review documents for regulatory submissions or internal processes to ensure regulatory compliance.
  • Provide and implement regulatory strategy and plans for a variety of product types with collaboration from all departments.
  • Keep abreast of regulatory requirements, including monitoring FDA and other global agencies regulations and standards, and communicate updates internal stakeholders.
  • Identify and manage issues that impact submission timelines or regulatory strategy, and communicate progress, including any risks, to Management.

For immediate considerations please email your resume to admin@snapstaffing.com



Posted On: Monday, March 15, 2021



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