About Ferring: By building strong relationships within the scientific community, our medical affairs team has become a trusted partner among patient groups, clinicians and health policy decision makers. We pride ourselves on developing and disseminating information to our key stakeholders so that they can provide the best care for our patients. Because we oversee the entire lifecycle for many of our products, we’re on the forefront of developing valuable and scientifically grounded information that will chart exciting paths forward for many of our innovative brands. Join our expert team and drive innovation. Job Description: Contribute to outstanding innovation Make braver choices Manager, CMC Regulatory Affairs Location: Parsippany As a privately-owned, specialty healthcare company, Ferring focuses on developing life-changing innovations that help people live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year commitment to science and research, Ferring is relentless in pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease. Responsibilities: Lead the preparation, planning, coordination, execution and ongoing maintenance of CMC regulatory submissions. Develop timelines for responses to FDA queries and ensure issues are addressed completely and in a timely manner; Prepare responses to complex questions and comments from FDA. Communicate submission quality standards and requirements to project teams. Serve as the regulatory expert on cross functional teams to ensure quality submissions. Assess and manage RA CMC change controls process for assigned products. Enter submission data into the Regulatory Information Management system and update RA CMC Databases. Manage the DMF Database. Maintain the CMC regulatory compliance for assigned products. Perform regulatory reviews of Annual Product Reviews and other internal documents. Manage projects guided by the Ferring USA Leadership Principles. Perform duties as assigned by the Supervisor. Requirements: Bachelor’s degree in a scientific field required; Masters or Ph.D a plus. Minimum of 10 years’ experience in the pharmaceutical industry. Minimum of 3-5 years of relevant experience in parenteral and biological product submissions in the Regulatory CMC area is required. IND, NDA & BLA CMC experience. Working knowledge of drug development, FDA statutes, regulations and guidance documents. Attend and participate in all team meetings. Excellent organizational and interpersonal skills. Excellent communication and presentation skills. Proficient in Microsoft Office. Working knowledge of eCTD submissions/electronic format. Prospective new hires for this position must be fully vaccinated against COVID-19 as a condition of employment. Vaccine verification will be required on your start date unless an exemption has been approved by the Company as a medical or religious accommodation. Join our team and you’ll become part of a close-knit family – one in which you’ll be listened to and your contributions valued. Surrounded by like-minded people, you’ll have the support to achieve more. So if you love to come up with new ways to make a positive difference and see them through, welcome to the team. We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We maintain a drug-free workplace and perform pre-employment substance abuse testing. Location: Parsippany, New Jersey