Regulatory Affairs Manager

Regulatory Affairs Manager

BioCare
Quality/Regulatory
Olive Branch, Mississippi
Posted 3 weeks ago

Looking for a great way to wrap up 2022? Apply today to join the BioCare team and be an integral part of a company that was recently included in the Inc. 5000 Fastest-Growing Private Companies in America. BioCare is a distributor of specialty pharmaceuticals that treat rare diseases, such as hemophilia, immune system deficiency and ALS. We are looking for a Regulatory Affairs Manager in the Olive Branch, MS area to join our growing Quality/Regulatory team and help us continue to be proactive and maintain our steadfast focus on compliance and customer/patient care. If you want to make a difference in people’s lives and support our ability to get the right medication into the right hands, at the right time, apply today to be part of the BioCare family!

Why you should apply:

  • Low cost and flexible medical, dental & vision plans
  • 17 days (136 hours) Paid Time Off accrued during your first year
  • Up to 40 hours Paid Sick Time accrued annually
  • 401k with 5% employer match
  • Company paid life and disability insurance
  • Competitive pay

Typical duties:

  • Responsible for regulatory (e.g., state, national and international) submissions, approvals, and maintenance, ensuring the completeness of filings to facilitate ease of regulatory review
  • Review incoming regulatory correspondence, determine target period for response to review letters, and respond in the required timeframe
  • Serve as the liaison to the regulatory/accrediting agencies (e.g., state Boards of Pharmacy, NABP, FDA, etc.)
  • Responsible for documenting recalls, and when necessary, providing regulatory notifications to the FDA regarding suspect illegitimate product
  • Assist the VP of Quality with preparations for external inspections and prepare responses to identified observations, issues or nonconformances
  • Responsible for evaluation of nonconforming products or materials, and when appropriate, collaborating with product titleholder and communicating effectively with internal/external customers regarding product related actions
  • Prepare regulated documents (policies, procedures, validations, etc.), ensuring they are complete, accurate, and are consistent with regulations and manufacturer’s instructions for use
  • Review and provide feedback on the comprehensive written agreement between parties involved in the contract manufacturing of drugs, to include storage and distribution, that defines and establishes each party’s activities and how they will comply with CGMP
  • Responsible for ensuring all facilities that handle the distribution of BioCare products follow the applicable laws governing that state for wholesale distribution and warehousing of products, and maintain necessary state permits/licenses
  • Develop regulatory KPIs that identify trends and areas for improvement and ensure staff fully comply with improvement actions for the identified issues; escalate as warranted
  • Analyze and communicate current regulatory guidelines and regulations, as well as industry and regulatory agency best practices, to keep leadership informed on any relevant changes in the regulatory landscape
  • Serve as the Privacy Officer, to include oversight of privacy SOPs and associated training of workforce members, investigation into privacy complaints, violations, and breaches, and coordination and oversight for privacy and HIPAA compliance
  • As warranted by growth of the department, supervise, train, and evaluate performance of assigned personnel, working closely with VP, Quality or HR to effectively resolve any personnel issues
  • Deliver quality customer service to all team members, customers, and stakeholders

Requirements:

  • Associate’s degree in related field or equivalent combination of education and experience
  • 5+ years of industry experience, including regulatory submissions in the healthcare, pharmaceutical, or life sciences industries
  • Intermediate knowledge of and experience with US FDA, EMA, and international pharmaceutical guidelines, regulations, and industry-standard practices
  • Strong regulatory, technical, statistical, and problem-solving skills
  • Experience and knowledge in the preparation of complex regulatory submissions and supportive documents
  • Strong organizational skills necessary to multi-task and manage various activities
  • Excellent interpersonal skills, including the ability to communicate effectively in both oral and written formats with regulatory agencies, customers, employees, and vendors at all levels
  • Ability to maintain professionalism and confidentiality, provide high levels of customer service, and work effectively with people, both inside and outside the organization
  • Ability to work independently and in a team environment
  • Proficient computer skills, including Microsoft Office Suite
  • Ability to organize, prioritize, and deliver results with a variable workload and multiple priorities
  • Ability to collaborate with others to identify inefficiencies and process improvements
  • Must be able to pass a drug test and background check aligned with state and federal laws and regulations

It’s a plus if you also have any of the following:

  • Bachelor’s degree in a related field
  • Working knowledge of the specialty distribution and third-party logistics industries, including pharmaceutical regulations (e.g., familiarity with Drug Distributor Accreditation (DDA) and Supply Chain Accreditation requirements)

 We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, gender, marital status, national origin, ancestry, disability, genetic information, medical condition, military/veteran status, sexual orientation, gender identity, gender expression, or any other characteristic protected by law.

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