Pharmaceutical Quality and Regulatory Manager

1 week ago

Carmel, United States Lauber Business Partners Full time $70,000 - $80,000
Job DescriptionJob Description

Job Overview: ParaPRO LLC is a pharmaceutical company located in Carmel, IN and is owned by Culpepper Holdings, LLC. ParaPRO’s current product offering includes Natroba™, a medication for head lice (pediculosis capitis), and scabies (sarcoptes scabiei var. hominis) in both adults and pediatric patients. The Quality & Regulatory Manager (QRM) will be a key driver in reviewing technical documents for cGMP compliance and will provide support to the Directory of Quality and Regulatory in areas including manufacturing compliance, human research study compliance, and state regulatory compliance matters.

Job Responsibilities Include: • Maintaining and organizing the documentation library • Review of documentation for drug product batches • Review and submission of marketing materials for compliance with the Office of Prescription Drugs Promotion regulations • Processing of state license renewals • Preparation for regulatory interactions • Conducting internal and external compliance audits • Representing Regulatory Affairs on project teams and providing regulatory guidance • Clearly and convincingly communicating complex issues • Sharing expert knowledge of complex issues • Reviewing technical documents for cGMP and regulatory compliance • Serving as an expert in technical areas in dealing with contract manufacturing organizations in the US • Assisting with and/or preparing high-quality submissions to the Food and Drug Administration (NDA’s, Supplements, Amendments, and Annual Reports) • Assisting with the Quality System • Communicating importance of quality assurance throughout the organization and with vendors • Keeping up to date on regulatory requirements including monitoring FDA and other agencies regulations and standards • Developing regulatory strategy for difficult issues which could significantly impact project timelines and costs • Providing regulatory decisions with regard to acceptability of submission documents and decisions • Assisting with the and/or filing of applications in accordance with predetermined timelines • Other duties as assigned. ParaPRO Job Description Page 2 of 2 Qualifications/Skills/Requirements: • At minimum, a bachelor’s degree in a scientific discipline and 5 years of experience in pharmaceutical Regulatory Affairs • Experience in preparing and filing IND, NDA’s, Supplements, Amendments and Annual Reports to FDA • Thorough understanding of the CFR, FDA/ICH guidelines and CGMP’s, as they pertain to pharmaceuticals • CMC understanding with knowledge of or experience with HPLC testing • Understanding of product development, manufacturing, sourcing, and servicing in the pharmaceutical environment • Project management, technical writing, and analytical skills. Effective process development and project management skills • Knowledge of pharmaceutical terminology • Good problem identification, analysis and solving skills • Must be proficient with Microsoft Office including the ability to develop MS PowerPoint presentations and Excel spreadsheets (including data manipulation and graphing). • Quality audit certification and/or Regulatory Affairs certification a plus • Experience building regulatory submissions according to the eCTD standard and filing through FDA’s ESG is a plus. • Works effectively in a team environment to ensure not only individual tasks are accomplished, but that team and department objectives are achieved • Dedicates time and energy to remove obstacles to facilitate achievement of team goals • Ensures that supervisor is aware of activities and progress • Projects professionalism and a courteous, cheerful and cooperative demeanor • Develops positive internal and external customer relationships • It is critically important the Q&R Associate be able to keep information confidential when required, not only from outside entities but to keep regulatory and manufacturing details and costs confidential strictly within the Q&R department of ParaPRO. Ability to travel is required. The chosen candidate will travel to contract manufacturing, research, and supply organizations as required by the quality and regulatory components of the job.

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