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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
Currently seeking for a Regulatory Affairs (RA) Manager with strong CMC pre and post approval experience to support Chiesi's Global Rare Diseases (GRD) global portfolio of commercial products. Open to candidates located near our offices in Boston, MA or Cary, NC. Main Responsibilities
- Authors and/or coordinate CMC activities for new 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.
- Assist in the development of regulatory strategies in alignment with GRD CMC-RA Head and Small Molecule Portfolio Lead for assigned projects, which may include both development and marketed products.
- Execute preparation of timely responses to small molecule CMC regulatory questions in coordination with impacted Subject Matter Experts (SME) as needed.
- Work collaboratively with external CMOs and cross-functional teams on projects like process optimizations, scale up and technology transfer activities.
- Reviews and assesses change control requests pertaining to CMC aspects of GRD products and coordinates filing strategies with minimal assistance.
- Support the creation and maintenance of CMC submission templates.
- Maintain submission information according to the document management system, track regulatory CMC commitments & timelines for specific projects/products/markets with minimal supervision.
- Contributes to the development of processes and the preparation of Standard Operating Procedures for RA CMC team as needed.
- Maintain sound knowledge of regulations, policies/guidelines, and keep abreast with current and evolving regulatory CMC requirements.
Experience Required
- 5 + years of experience in Small Molecules, Herbal Medicinal Products or Biologics focused on Regulatory CMC
- Advanced knowledge of current global CMC regulations, including ICH requirements and US/EU regulatory requirements.
- Sound knowledge of China and Japan regulatory requirements
- Experience in authoring technical documents, CTD M2 and M3 sections, and life cycle management of quality variations.
- Proficient in the use of quality management software (e.g. TrackWise) and regulatory document information management system is an asset.
- Strong attention to detail.
- Proven ability to multi-task, stay organize and prioritize.
- Strong communication skills (oral, written and interpersonal); critical thinking and the ability to identify and recommend solutions to problems.
- Ability to work independently and in a group setting and thrive in a fast-paced environment.
Education
Minimum of a Bachelor's Degree in a Scientific or Technical Discipline; Advanced Degree preferred. 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.
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Chiesi
Jan 24, 2025