Regulatory Affairs Associate Job at cGxPServe, New Jersey

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  • cGxPServe
  • New Jersey

Job Description

Responsibilities:
  • Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
  • Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
  • Responsible for managing and compiling CMC sections of marketed product variations.
  • Partner with RA CMC Project Leads and develop module 3 content and project timelines.
  • Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
  • Skills for running review meetings for submission documents.
  • Understand CMC expectations including CTD content, structural and formatting requirements.
  • Maintains awareness of and utilizes current best practices for use of regulatory business systems within the group.
  • Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
  • Review/approval of engineering study protocols/reports and validation study protocols/reports.
  • Review and approval of manufacturing changes for Class III implantable medical devices.
  • Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight.
  • Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
  • Independently facilitate project team meetings.
  • Superior oral and written communication skills
  • Ability to work cooperatively with all levels and types of global personnel required
  • Experience working with electronic document management systems
  • Ability to work independently. Manage multiple projects simultaneously.
  • Stay attuned to shifts in project scope, business objectives, and team feedback, adjusting priorities and strategies as necessary.
  • Detail/accuracy oriented, collaborative and willing to learn
  • Familiarity with US and other international regulatory requirements for dossiers.

Requirements:

  • Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline.
  • 4 years pharmaceutical. 1-2 years cross functional project management.
  • 5 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3).
  • May require an advanced degree and 3 to 5 years of direct experience in the field.
  • Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
  • Relies on extensive experience and judgment to plan and accomplish goals.
  • Performs a variety of tasks.

Job Tags

Shift work,

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