Supervisor, Reg Affairs

Job description

**This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Supervisor, Regulatory Affairs based in the United States.** The Supervisor, Regulatory Affairs will oversee critical regulatory operations across pharmaceutical and medical device product portfolios, ensuring compliance with applicable FDA requirements and industry standards. You will lead a team of regulatory and quality specialists responsible for product labeling approvals, drug listings, medical device identification submissions, and regulatory documentation. Working closely with Quality Assurance, Packaging Operations, Commercial Product Development, Legal, and external partners, you will resolve complex compliance challenges and strengthen operational processes. You will play a key role in maintaining accurate regulatory databases, managing quality investigations, and supporting risk assessments that protect product integrity and patient safety. In addition, you will refine standard operating procedures, promote consistent quality practices, and ensure regulatory submissions are accurate and timely. This nationwide remote opportunity is ideal for an experienced regulatory professional who combines technical expertise with people leadership and a commitment to continuous improvement in a highly regulated healthcare environment. ### Accountabilities - **Regulatory Leadership and Team Supervision:** Direct daily activities for labeling and listing specialists and senior specialists, providing coaching, technical guidance, and performance support. Reinforce internal policies, procedures, and quality standards while ensuring the team consistently meets regulatory and operational objectives. - **Labeling and Packaging Approvals:** Oversee and support Quality Assurance reviews and approvals for prescription and over-the-counter pharmaceutical private-label products. Review labeling components within Master Batch Records and repackaging requests, ensuring packaging and labeling materials meet applicable regulatory and quality requirements. - **Claims and Package Insert Compliance:** Review and approve product claims, bio-food statements, and California Proposition 65 assessments to ensure marketing and labeling materials comply with relevant requirements. Oversee proofreading, revision management, and final disposition of package inserts. - **Quality Investigations and Market Action Support:** Collaborate with Quality Assurance managers and cross-functional teams to investigate complex packaging and labeling deviations. Coordinate the collection of defect photographs and complaint samples, establish the scope of potential root causes, and provide the information needed to determine appropriate market action boundaries. - **Health Hazard Evaluations:** Coordinate and prepare Health Hazard Evaluations (HHEs) in collaboration with clinical and medical safety experts. Support risk assessments and potential market action decisions by ensuring relevant documentation and regulatory considerations are addressed. - **Drug Listing and FDA Submissions:** Oversee drug listing activities for pharmaceutical private-label products, providing technical review and guidance to support accurate, timely FDA submissions. Maintain compliance with applicable CARES Act reporting requirements and FDA certification periods. - **Medical Device Identification and Regulatory Systems:** Manage Unique Device Identification (UDI) data submissions to the Global Unique Device Identification Database (GUDID). Maintain regulatory labeling workflows and data integrity within the Kallik management system and other applicable regulatory platforms. - **Standard Operating Procedures and Process Improvement:** Develop, review, and update standard operating procedures (SOPs) to strengthen compliance, standardize workflows, and improve operational efficiency. Monitor adherence to established policies and implement refinements that support consistent, high-quality regulatory execution. - **Cross-Functional and External Collaboration:** Serve as a key regulatory liaison among Quality Assurance, Packaging Operations, Commercial Product Development, Pharmaceutical Product Sourcing, Legal, and external vendor Quality Assurance teams. Facilitate discussions, resolve complex regulatory questions, and build alignment among internal and external stakeholders. - **Quality Agreements and Compliance Alignment:** Lead collaborative discussions concerning quality agreements and help ensure external partners understand and meet relevant quality and regulatory expectations. - **Regulatory Risk Management:** Apply regulatory expertise to identify compliance risks, resolve complex issues, and develop practical solutions that protect product integrity, maintain database accuracy, and support uninterrupted, compliant supply chain operations. ## Requirements - **Professional Experience:** Four to eight years of experience in Pharmaceutical or Medical Device Quality Assurance or Regulatory Affairs. Experience supporting private-label products is preferred, particularly in environments involving labeling approvals, drug listings, and regulatory compliance. - **Education:** A bachelor's degree in a relevant scientific or technical discipline is preferred. Equivalent practical experience may also be considered. - **Regulatory Knowledge:** A strong understanding of pharmaceutical and medical device regulatory requirements, including applicable FDA regulations, labeling standards, product listing obligations, and quality system procedures. Familiarity with FDA Compliance Policy Guides (CPGs), 21 CFR Part 11, and United States Pharmacopeia (USP) testing standards is preferred. - **Labeling and Quality Assurance Expertise:** Experience reviewing pharmaceutical labeling and packaging components, managing product documentation, evaluating claims, and resolving quality deviations. Familiarity with risk assessments, complaint investigations, root-cause analysis, and market action support is an advantage. - **Regulatory Systems Proficiency:** Experience with regulatory and quality management platforms such as Kallik, FACTS, or Veeva Vault QMS is preferred. Working knowledge of eDRLS and I4I/A4L software applications used for FDA drug listing submissions is also desirable. - **Drug and Device Listing Experience:** Familiarity with FDA drug listing processes, UDI requirements, GUDID submissions, and associated regulatory documentation. The ability to maintain accurate regulatory data and coordinate submissions within established timelines is important. - **Leadership and Coaching Skills:** Demonstrated ability to supervise, mentor, and support regulatory or quality professionals. Strong organizational skills and the ability to establish priorities, monitor performance, and reinforce consistent operational standards are essential. - **Analytical and Problem-Solving Abilities:** Strong attention to detail and the ability to investigate complex regulatory issues, assess potential compliance risks, interpret technical information, and recommend practical corrective actions. - **Communication and Stakeholder Management:** Excellent written and verbal communication skills, with the ability to work effectively across multidisciplinary teams, facilitate discussions with senior stakeholders, and coordinate with external quality and regulatory partners. - **Process Improvement Mindset:** Experience developing or refining SOPs, strengthening quality systems, and improving workflows to increase efficiency while maintaining regulatory compliance. - **Location and Work Arrangement:** This is a full-time, nationwide remote position open to candidates located in the United States. ## Benefits - **Competitive salary:** Anticipated annual salary range of **$79,700–$117,200**, depending on geographic location, education, experience, skills, and internal pay equity considerations. - **Healthcare coverage:** Medical, dental, and vision insurance options to support your health and well-being. - **Retirement savings:** Access to a 401(k) savings plan to help you plan for the future. - **Health savings account:** HSA options to help manage eligible healthcare expenses. - **Flexible spending accounts:** FSAs to support eligible healthcare and other qualified expenses. - **Paid time off:** A paid time-off plan to support personal needs, rest, and work-life balance. - **Paid parental leave:** Leave benefits to support employees and their families. - **Disability coverage:** Short-term and long-term disability benefits. - **Financial flexibility:** Access to myFlexPay, which allows eligible employees to access earned wages before payday. - **Work-life resources:** Programs and resources designed to support employees' personal and professional well-being. - **Healthy lifestyle programs:** Initiatives that encourage healthy habits and support overall wellness. - **Remote work flexibility:** The opportunity to work remotely from anywhere within the United States. - **Inclusive workplace:** A commitment to equal employment opportunities, diversity, and a respectful environment where employees can contribute authentically and feel valued. - **Meaningful professional impact:** The opportunity to lead regulatory operations that help maintain the quality, compliance, and integrity of pharmaceutical and medical device products.