Manager, Regulatory Affairs Operations, Rare Diseases

Chiesi
United States, Massachusetts, Boston
One Boston Place, Suite 4000 (Show on map)
Jan 10, 2025
*About us* Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care). We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels. We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. *Chiesi USA* Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work. At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work. *What we offer* Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that "Every one of us is different. Every one of us is Chiesi." *Who we are looking for* Purpose Perform and oversee strategic and operational aspects of Chiesi regulatory submissions, ensuring that the submissions are of highest quality, delivered on-time, and within the established budget. Perform and oversee the effective and appropriate management of Chiesi regulatory documentation. Main Responsibilities Ensure all submissions are published timely to meet Health Authorities timelines and business priorities and to the highest publishing standard; Ensure adequate capacity for upcoming submissions and competing priorities (in-house and publishing vendors); Liaise with publishing vendors and triage some of the publishing work to them, based on publishing priorities and available resources in-house ; Consult and review on regional eCTD technical requirements (e.g. metadata, dataset format etc.); Provide recommendations and requirements for pre-submission preparation (e.g. template use, style guides, etc.); Implement new version/upgrade of eCTD to streamline publishing process as needed. Experience Required Minimum of 5 years' experience in a Regulatory Operations role. Knowledge expert regarding global regulatory submission standards, software validation concepts, and publishing best practices. Demonstrated expertise with submission publishing tools (eCTD building tools); hands-on experience with publishing, validating, and submitting a full marketing application in CTD format in the US/EU required. Ability to work independently with moderate supervision; ability to communicate and interact with a variety of personnel, including management and external vendors; ability to direct operational staff to achieve submission publishing timelines successfully. Excellent organizational skills, sufficient to multi-task and manage project timelines in an extremely fast-paced environment with changing priorities. Excellent knowledge of Word and Adobe Acrobat Pro required. Education Bachelor's Degree in Science. Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one's employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.