Manager, Regulatory Affairs Support Job in Westborough, Massachusetts US
Manager, Regulatory Affairs Support
Job Description Job Number: 1477814 Business GE Healthcare Business Segment: Healthcare Life Sciences About Us: What do you envision for your future? At GE Healthcare, our vision involves looking at Healthcare in a completely new way. Focusing on earlier, pre-symptomatic disease detection and prevention, instead of late diagnosis. Helping clinicians access more information and intervene sooner with targeted treatments so their patients can live longer, fuller lives. We believe we can help make that happen and wed like you to be a part of our mission. As a global leader, GE can bring together the best in science, technology, business and human resources to redefine the frontiers of healthcare. Something remarkable happens when you bring together people who are driven to make a difference they do. ---Your Life. Your career. Your purpose. Re-imagined--- About our Life Sciences business: Life Sciences delivers breakthroughs in drug discovery, biopharmaceutical manufacturing and the latest in cellular technologies, so scientists and specialists around the world discover new ways to predict, diagnose and treat disease earlier. The Life Sciences business also makes systems and equipment for the purification of biopharmaceuticals. What makes GE Healthcare different? Leadership Learning - Learning is more than a classroom activity. Its how we come together to embrace change, develop skills for change, and get energized. GE spends more than $1 billion annually in employee development and leadership training. What makes GE Healthcare different? High-integrity business practices - Ours is an invigorating, high performance environment that emphasizes high-integrity business practices. We seek to lead in workplace and marketplace integrity by respecting the human rights of everyone touched by our business, and by enforcing legal and financial compliance. What makes GE Healthcare different? Culture at a personal level - We all have varying priorities at different stages in our lives. Recognizing that this may mean different things to different people, GE Healthcare strives to meet the needs and desires of its employees on a personal level. This is accomplished by working to align career opportunities with the priorities of talented individuals throughout the organization. What makes GE Healthcare different? Committed to personal growth - At GE Healthcare, we pride ourselves on growing leaders of tomorrow. Our people, processes, and culture are designed to support and grow the individual, giving them the opportunity to develop their skills in a variety of ways while moving throughout the organization. We are dedicated to helping you build a career at GE Healthcare. What makes GE Healthcare different? Total Rewards - GE Healthcare focuses on the total reward package in order to attract, engage and retain top talent in the organization. With a structure that rewards performance, behaviors and values, GE Healthcare is proud to offer competitive compensation and benefit plans at all levels of the organization. What makes GE Healthcare different? Community Involvement - We believe a company does well when it does good. This belief drives organizational practices from the philanthropic efforts of the GE Foundation to the millions of volunteer hours donated by our employees towards community initiatives worldwide. Posted Position Title: Manager, Regulatory Affairs Support Career Level: Experienced Function Marketing Function Segment: Marketing Operations Location: United States U.S. State, China or Canada Provinces: Massachusetts City: Westborough Postal Code: 01581-1019 Relocation Assistance No Role Summary/Purpose: Customer Regulatory Support is a resource within BioTechnologies to support product managers, regions and customers, and provide quality documents, standard or on request, and online support in response to customers requests for quality, regulatory and technical related information. Customer Regulatory Support aims to adding value tol BioTechnologies products, demonstrating commitment to customer satisfaction. Essential Responsibilities Responsibilities include but are not limited to: - Maintain knowledge and understanding of regulatory requirements related to BioProcess business at a high level - Support development of regulatory documentation for filters, cellbags and most ReadyToProcess products - Develop and update regulatory support documentation - Respond efficiently and promptly to customer regulatory based issues (CSSx) - Perform necessary investigations, prepare and deliver certificates or statements - Participate in creating and updating guidelines and steering documents ESSENTIAL TASKS: - Act as dicussion partner to RD, QA, Product Management and other functions and regions on regulatory issues - Participate in project teams as regulatory expert - Respond efficiently and promptly to customers regulatory based issues (within CSSx). This will include necessary investigations, preparations and delivery of certificates, use of available internal and external databases and other relevant databases. - File and maintain complete documentation of questions and answers in databases. Specify, prepare, update and review regulatory support documentation; VG, CCN, statements, certificates and other regulatory related documentation for new and existing products. - Use existing web based system and expand regulatory information provided on the web - Take part in creating and updating guidelines and steering documents Qualifications/Requirements: - Bachelor of Science in Chemistry, Biotechnology, Chemical Engineering or other Life Sciences discipline - 3+ years of experience with/knowledge of Regulatory requirements and bodies in the US - Experience in Life Sciences/Biotechnology industry Additional Eligibility Qualifications GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen. Desired Characteristics - Understanding of GMP - Knowledge of regulatory requirements with BioProcess products - Experience from industry regarding biopharmaceutical process development, stability issues and quality assurance - Experience with GE Healthcare product development or production - Skills with the related systems; Lotus Notes, Magic, etc - Organized, target and customer oriented - Flexible and service minded with good collaborative skills - High ability to work independently