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Regulatory Affairs CMC Specialist - Contract

Chiesi
United States, Massachusetts, Boston
One Boston Place, Suite 4000 (Show on map)
Jun 11, 2025
*About us* Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with 90 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 Currently seeking for a Regulatory Affairs Specialist to support preparation of CMC related submissions and assessment of quality change controls for Chiesi's Global Rare Diseases (GRD) global portfolio of commercial products. Main Responsibilities Prepares and/or coordinate CMC activities for new product registrations, post approval changes, renewals, annual reports, and extension applications ensuring on-time and high-quality global submissions. Interface with external Contract Manufacturing Organizations (CMO) and relevant functional teams in obtaining the necessary CMC documentation in support of a regulatory submission. Execute preparation of timely responses to CMC regulatory questions in coordination with Subject Matter Experts (SME) as needed. Reviews and assesses change control requests pertaining to CMC aspects of GRD products and coordinates filing strategies with minimal assistance; attend change control meetings as regulatory-CMC representative. Maintain submission information according to the document management system, track regulatory CMC commitments & timelines for specific projects/products/markets with minimal supervision. Maintain sound knowledge of regulations, policies/guidelines, and keep abreast with current and evolving regulatory CMC requirements. Participate in ad-hoc or special regulatory projects as needed. Experience Required Pharmaceutical Regulatory Affairs certification preferred. 2 + years of experience in Regulatory Affairs specifically with Small Molecules focused on Regulatory CMC Good understanding of the drug development and life-cycle management process Familiarity with global CMC regulations, including ICH requirements and US/EU and Health Canada regulatory guidances Experience in authoring technical documents, CTD M2 and M3 sections, and life cycle management of quality variations/supplements Strong oral and written communication skills with superior attention to detail Demonstrates initiative and is proactive; ability to work independently and within a team setting. Proficiency in Microsoft Office programs and other regulatory databases (e.g. Trackwise, Veeva, eCTD publishing software) Education Minimum of a bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, Chemistry) 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.