Regulatory Affairs Manager

BioCare



Quality/Regulatory



Olive Branch, Mississippi



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.