Senior Associate Drug Regulatory Associate(Remote)

11/12/20

Columbus, OH 43232

1090

FullTimeRegular

Sr. Regulatory Affairs Associate (Ohio or New Jersey)

Overview

Serves as a Subject Matter Expert (SME) for regulatory activities of R&D and/or lifecycle submissions to US FDA. This includes, but is not limited to, the compilation, review and submission of pre-approval (R&D) and/ or post-approval (lifecycle) submissions, such as original applications, amendments and deficiency responses, annual reports, supplements, supplement deficiency responses, and general correspondence for all regulatory submissions with a focus on Chemistry, Manufacturing and Controls (CMC) and Labeling. The candidate will be responsible for providing expert support in applicable team meetings and when consulted, and operate as a SME regarding regulatory guidances/regulations and strategies to other members of the regulatory department, as well as to other departments. The candidate will be expected to mentor and provide regulatory support to other associates within the group, as well as within the organization. Requires minimal to no supervision.

Responsibilities

  • Compiles, reviews and submits applications, amendments and/or lifecycle changes (focus on CMC and Labeling) for the US market. Regulatory submissions such as annual reports, supplements, amendments for ANDAs and NDAs will be submitted to FDA as per the business needs and compliance with all FDA requirements.
  • Reviews change controls for regulatory impact and documentation to be included in regulatory submissions (i.e. batch records (manufacturing, packaging), specifications, analytical methods, etc.)
  • Provides expert support as a regulatory subject matter expert and work closely with cross-functional departments (i.e. Quality Assurance, Quality Control, Technical Services, Product Development, Analytical Development, Project Management etc.) to provide the appropriate regulatory requirements/guidance, as applicable. Support will also be provided to cross functional teams for applicable submissions to US FDA.
  • Performs thorough review of peer submissions to ensure submission quality and compliance with current guidance and regulations. Serves as first line expert in fielding regulatory questions for the organization.
  • Stays current with emerging regulatory guidance, and industry expectations and standards, and demonstrates the ability to translate these into process improvements or best practices. Actively looks for ways to improve current processes within department and across the business to gain efficiency and quality submissions to US FDA.
  • Other duties as assigned.

Qualifications

  • Minimum of a Bachelor’s degree required (Science related field)
  • Pharmaceutical experience a minimum of 6 years of regulatory submission experience

Job-Specific Competencies:

  • Thorough understanding and expert knowledge of regulatory requirements for pre-approval and/or post-approval submissions for the US Market.
  • Thorough understanding of regulations and requirements for US market through expert knowledge, FDA Guidance Documents and MAPPs, ICH Guidelines, Code of Federal Regulations as they pertain to generic drug products.
  • Demonstrates the ability to ensure high quality submissions to US FDA are submitted as per the business.
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