Regulatory Affairs Manager

BEPC is actively looking for Regulatory Affairs Manager I in the Indianapolis, IN area! W2 Contract - Approximately 12 months with possible extensions! Benefits include medical, dental, vision, and life insurance Work Model: Hybrid - 1st shift; 3 days onsite and 2 days remote. Note: This is a W2 only role - C2C, C2H will not be considered Summary of the Role: BEPC is seeking a highly motivated Regulatory Affairs Manager I to join our client’s site in Indianapolis, Indiana. This role will support obtaining regulatory approvals for products within the assigned area of responsibility in close cooperation with other functions. The position coordinates and compiles submission documents and deliverables in a timely manner to support planned product registration timelines. The Regulatory Affairs Manager I will maintain regulatory approvals and product licenses throughout the product life cycle by applying successful regulatory change controls. The role will support the efficiency and success of regulatory activities and strategies through clear agreements with other functions, stakeholders, and external partners, including authorities, companies, and notified bodies. The position ensures regulatory requirements and strategic considerations are understood, communicated, implemented, kept current, and transparent throughout the organization. Activities are driven by a mindset of innovation, agility, and the principles of VACC leadership. Summary of Duties and Responsibilities: Oversee the development of submission and product registration dossiers for more complex products and programs. Develop and manage portions of comprehensive global regulatory submissions and registration plans. Serve as a mentor to more junior team members in regulatory document and submission compilation. Effectively partner with stakeholders to understand their needs and provide the best solutions. Take the initiative to address problems or opportunities and involve stakeholders in identifying solutions. Develop external relationships that significantly influence the current and future direction of the organization and its products. Contribute to audit preparation and potentially participate in audit discussions. Lead the organization in adapting to evolving regulatory environments and requirements. Solve complex and critical health authority issues or equivalent regulatory matters. Understand external environmental changes and precedents to navigate complex situations and influence strategies and decision-making. Interpret and apply an understanding of regulators’ thinking to projects and adapt strategies to the different needs of various regions without significant guidance. Proactively create innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals. Develop relationships that significantly influence the current and future direction of the organization and its products. Understand what motivates others to perform at their best and effectively manage and influence peers. Foster the exchange of ideas among key stakeholders, shift perspectives, negotiate with stakeholders, and create mutually beneficial compromises to reach common outcomes. Make decisions, including decisions outside the position’s usual scope or comfort zone. Independently initiate activities and interactions across departments, as applicable. Apply good decision-making principles, push decisions to the lowest appropriate level, commit to established decisions, exercise sound judgment, and make timely decisions without necessarily having all available information. Drive innovation across the organization and its sites by advocating for and advancing new ideas that add business value. Recognize the value of others’ unique differences, pursue new opportunities, and help introduce new ideas into the business. Troubleshoot issues as they arise and independently develop and implement cost-effective, non-complex solutions to ensure daily work is completed without jeopardizing compliance. Identify problems before they occur, actively develop mitigation strategies, and lead others in problem-solving activities. Embrace the principle that everyone leads, identify opportunities to develop VACC competency, act with integrity, courage, and passion, and honor commitments. Contribute to an inclusive environment that supports all dimensions of diversity, explore opportunities for leadership and future contributions, and take initiative when opportunities arise. Serve as a change ambassador by actively developing an agile mindset and behaviors and encouraging others to do the same. Identify and act on improvement opportunities across Quality and Regulatory. Embrace new technologies and other approaches that simplify work and increase productivity. Take ownership of regulatory data, promote data stewardship within Regulatory Affairs teams, and use and encourage the use of all regulatory tools. Contribute to or lead projects with an understanding of how business functions, systems, processes, and data management are connected and essential to achieving digitalization and strategic goals. Mentor junior regulatory employees and actively share knowledge throughout the organization. Bring people together around common goals and seek to understand and build on different perspectives to enhance outcomes. Address and resolve conflict by creating an atmosphere of openness and trust. Bring out the best in individuals and teams and ensure people feel heard. Communicate complex ideas fluently and clearly and encourage direct, open discussions about important issues. Communicate truthfully regardless of the circumstances and recognize, reflect, and articulate multiple perspectives on an issue. Provide honest input in difficult situations, speak up, participate actively, and create an environment of recognition and appreciation. Qualifications: Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices. PhD: 3-5 years of experience in IVDs, medical devices, pharmaceuticals, or biopharmaceuticals, with significant Regulatory Affairs or equivalent experience. Master’s degree: 5-7 years of experience in IVDs, medical devices, pharmaceuticals, or biopharmaceuticals, with significant Regulatory Affairs or equivalent experience. Bachelor’s degree: 6-8 years of experience in IVDs, medical devices, pharmaceuticals, or biopharmaceuticals, with significant Regulatory Affairs or equivalent experience. Demonstrated ability to manage highly complex work and/or at least portions of global projects. Preferred Qualifications: Knowledge of European, United States, Chinese, and other international regulations. Demonstrated ability to adequately interpret and implement quality standards. About BEPC BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth. #J-18808-Ljbffr BEPC Inc. - Business Excellence Professional Consulting