Fresenius Medical Care North America Regulatory Affairs Associate – Pharmaceuticals in Waltham, Massachusetts

Regulatory Affairs Associate – Pharmaceuticals, Fresenius USA Marketing, Inc., a Fresenius Medical Care N.A. company, Waltham, MA

Purpose and Scope:

Will work to ensure that all company pharmaceutical products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance.

Principal Duties andResponsibilities:

  • Organizing regulatory information resources and tracking andcontrolling submissions. Reviewing and advising on labeling, protocols, andChemistry Manufacturing and Control (CMC) changes for compliance withregulatory filings.

  • Collect and coordinate information required for regulatorydocumentation packages for review and submission to regulatory agenciesensuring compliance with all applicable policies, procedures and regulatoryrequirements and guidelines. This includes:

  • Authoring eCTD sections (CMC) for FDA submissions necessary fordrug approval, including New Drug Applications (NDAs), Abbreviated New DrugApplications (ANDAs), Investigational New Drug Applications (INDs), and relatedamendments and supplements;

  • Coordinating and reviewing documentation received fromcross-functional team members (from R&D, Manufacturing, Medical Affairs andDistribution) for accuracy, completeness and to ensure compliance withapplicable regulations and requirements. Identifying discrepancies andaddressing them with team members and/or management for resolution prior tosubmission;

  • Compiling materials for periodic submission updates for AnnualReports and assembling/coordinating submission of Periodic Adverse EventReports (PADERs). Reviewing information from Clinical/Pharmacovigilance groupand submitting Annual Product Reports and PADERS; and

  • Monitoringsubmissions to ensure adherence to established/proposed timelines,investigating and addressing identified discrepancies.

  • Liaison with relevant groups and organizations. Researchinformation for responding to various questions or requests for informationfrom groups including the FDA and other FMCNA departments. Prepare all thenecessary forms and completing the response documentation according to requiredspecifications.

  • Research, develop and recommend submission strategies forsuccessful acceptance of NDA’s and ANDA’s.

  • Monitoring and maintaining the regulatory files database andchronologies in good order. Working with other team members to maintain a systemfor tracking changes in documents submitted to agencies. Contributing todevelopment of systems, as needed, to improve tracking and documentation needs.

  • Maintain current knowledge of drug regulations, guidance, andstandards applicable for drug product submissions. Analyzing the informationregarding changes and updates.

  • Advises and recommends as needed to management and potentiallyimpacted personnel/departments any new regulation and guidance that impactFMCNA products.

  • Assist with compliance activities and provide regulatoryintelligence of competitor products as necessary.

  • Participate in departmental continuous improvement activities.Making recommendations for process improvements to improve efficiency andaccuracy of drug submissions and other procedures.

  • Review and comply with the Code of Business Conduct and allapplicable company policies and procedures, local, state and federal laws andregulations.

Education Experience and RequiredSkills:

This position requires either (i) a Master’s degree (or equivalent foreign degree) in Regulatory Affairs or Pharmacy and 3 years of experience as a Regulatory Affairs Associate, or (ii) a Bachelor’s degree (or equivalent foreign degree) in Regulatory Affairs or Pharmacy and 5 years of experience as a Regulatory Affairs Associate. Must also have 3 years of experience - which can have been gained concurrently with the primary experience requirement above - with the following:

  • Drafting eCTD submissions which includes writing and reviewing thetechnical documents.

  • Researching and summarizing all relevant regulatory challengeswhich might impact a product.

  • FDAregulations and guidance for pharmaceuticals.

  • Developingand implementing regulatory CMC (Chemistry, Manufacturing and Controls) forgeneric pharmaceutical product development.

  • Preparing initial REMS (Risk Evaluation and Mitigation Strategy)and subsequent REMS amendments.

  • 21CFR Part 820 and Part 211 compliance requirements.

  • ISO14971 and ISO 13485 requirements for regulatory compliance.

Position requires between 10-15% domestic and international travel.