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Regulatory Affairs Specialist III

2 months ago

Camden, United States System One Holdings, LLC Full time
Job Title: Regulatory Affairs Specialist III
Location: Camden, NJ
Type: Contract, Potential for extension or conversion to permanent

Responsibilities
  • Compile and maintain regulatory documentation databases or systems.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Analyze product complaints and make recommendations regarding their reportability.
  • Develop or conduct employee regulatory training.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
  • Participate in internal or external audits.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Recommend changes to company procedures in response to changes in regulations or standards.
  • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
  • Review clinical protocols to ensure collection of data needed for regulatory submissions.
  • Write or update standard operating procedures, work instructions, or policies.
  • Coordinate recall or market withdrawal activities as necessary.
  • Develop or track quality metrics.
  • Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
  • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
  • Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
  • Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
  • Monitor national or international legislation on ozone-depleting substances or global warming.
  • Obtain clearances for the use of recycled plastics in product packaging.
  • Determine the effects of legal requirements related to the production, supply, or use of ozone-depleting substances or equipment containing such substances.
  • Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
Requirements
  • B.S. food science, nutrition, chemistry or related OR M.S. food science, nutrition, chemistry or related with minimum of 3 years experience with pharma/food ingredients and formulations in an industry or government setting
  • Experience w Optiva, or similar formula management system would be a plus like GENESIS


Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.