Title Associate, Regulatory Affairs
Job Summary

 

The Associate, Regulatory Affairs supports the Regulatory Affairs team in day-to-day activities to ensure the timely compilation and submission of INDs, NDAs, ANDAs, Annual Reports, Periodic Reports, Amendments/Supplements, and Deficiency Letter Responses to the FDA.

Responsibilities
  • Review technical/regulatory/clinical documentation related to INDs, NDAs, ANDAs, or other applications, as assigned, to support original submissions, amendments, supplements, and annual reports.
  • Author and compile supplements/amendments to support department goals and meet FDA timelines.
  • Prepare electronic files for inclusion in eCTD submissions, per the applicable guidelines.
  • Evaluate proposed changes to applications versus current available guidance documents and formulate filing strategies and filing requirements.
  • Prepare and submit Annual Reports and PADERS in accordance with the established schedule and per applicable guidelines.
  • Create, revise, and maintain drug product labeling.
Qualifications
  • Bachelor’s degree in a science (preferably Biology, Chemistry, Pharmacy).
  • Minimum of 2 years of pharmaceutical industry experience.
  • Proficient in Microsoft Windows environment including, but not limited to, Microsoft Office products; Adobe Acrobat and plug-ins; document management systems;
  • Ability to learn new technology and apply to business needs.
  • Ability to read, analyze, and interpret scientific and technical Agency guidance. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the technology community.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts
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