What are the responsibilities and job description for the Manager, Regulatory Affairs Operations, Rare Diseases position at Chiesi Farmaceutici S.p.A.?
Select how often (in days) to receive an alert :
Manager, Regulatory Affairs Operations, Rare Diseases
Date : Jan 10, 2025
Department : GRD Regulatory Affairs
Job Type : Direct Employee
Team : R&D, Pharmacovigilance & Regulatory Affairs
Contract Type : Permanent
Location : Boston, MA, US
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 researches, develops, and markets innovative drugs in its three therapeutic areas : AIR RARE , and CAR . 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.
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.
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.
Purpose
Perform and oversee strategic and operational aspects of Chiesi regulatory submissions, ensuring that the submissions are of the highest quality, delivered on-time, and within the established budget.
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
Education
Bachelor’s Degree in Science.
Chiesi USA is an equal opportunity employer committed to hiring a diverse workforce 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.
J-18808-Ljbffr
