Regulatory Affairs Senior Associate/Manager

1 week ago

Florham Park, New Jersey, United States Exeltis Full time
Job Overview

Position Summary:
As a key member of the Regulatory Affairs team, you will take on the role of Regulatory lead, overseeing submission planning and strategy for both developmental initiatives and existing FDA-approved products. Your expertise will be crucial in preparing high-quality ANDA submissions, including amendments, supplements, and Annual Reports, under the guidance of the Senior Manager or Associate Director of Regulatory Affairs.

Key Responsibilities:

CMC Regulatory Affairs
  • Serve as the Regulatory Affairs lead for designated projects, ensuring the accuracy and completeness of eCTD submissions (ANDA, Supplements, Amendments, and Annual Reports).
  • Keep senior Regulatory Affairs management informed of critical project developments and their potential implications for regulatory submissions, identifying any challenges that may arise during FDA reviews.
  • Collaborate with various stakeholders within the organization to gather necessary documentation for regulatory submissions, ensuring adherence to departmental timelines.
  • Assist in the creation and evaluation of technical documents, ensuring they meet the standards for new ANDAs, Amendments, Supplements, Annual Reports, and other FDA-required filings.
  • Review and approve change controls, assessing their impact on business operations based on a comprehensive understanding of regulatory guidelines and applicable FDA regulations.
Labeling and Promotional Review
  • Prepare various regulatory labeling submissions.
  • Review and ensure timely completion of labeling for ANDA dossiers, addressing any deficiencies to secure approval.
  • Submit updated labeling in eCTD format to the FDA.
  • Evaluate labeling revisions and private label products.
  • Initiate and approve change controls related to artwork and labeling.
  • Possess the ability to work on SPL labeling.
Regulatory Operations
  • Manage the tracking and filing of FDA correspondence, including communications and relevant documentation.
  • Collaborate with cross-functional teams to support regulatory activities for drug product submissions.
  • Maintain and update spreadsheets and databases promptly.
  • Responsible for drafting and reviewing Modules in eCTD, ensuring proper hyperlinking and functionality of navigational tools.
  • Publish and compile documents while adhering to FDA standards and internal protocols.
  • Effectively prioritize tasks in a fast-paced, dynamic environment.
Additional Responsibilities
  • Train and support staff in preparing electronic drug listing information (SPL, PLR) for the FDA.
  • Process, prepare, assemble, compile, and publish regulatory submissions in Electronic Common Technical Document (eCTD) format as necessary.

Qualifications:

  • Education: A minimum of a bachelor's degree in a life science or pharmacy-related field; an advanced degree in Manufacturing, Chemical, Pharmaceutical, or Biological Sciences is preferred (RAC certification is advantageous).
  • Languages: Proficiency in English; Spanish is a plus.
  • Experience: At least 4 years in the Generic Pharmaceutical Industry, with a minimum of 3 years in Regulatory Affairs.
  • Knowledge: Familiarity with regulatory practices for generic drugs and FDA guidelines.
  • Travel: Up to 5% for potential overseas visits to manufacturing sites or CROs.
  • Personal Skills: Strong management capabilities, interpersonal skills, results-oriented mindset, superior leadership qualities, and problem-solving abilities.

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