Global Regulatory Affairs Manager
4 days ago
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.‘
PurposeThe Global RA Managersupports the Global Regulatory Teams in the translation of regulatory requirements into practical application to ensure the success of pre-approval drug development programs. Supports regulatory agency interactions, communications, and preparation of submissions.
Main Responsibilities- Independently coordinates the request to Affiliates and Partners of the regulatory requirements applicable to supported regions or areas of responsibility.
- With guidance from Unit Head, assist in the identification of the EU and US regulatory requirements applicable to supported regions or areas of responsibility
- With guidance from Unit Head, assist in the preparation and presentation of regulatory information at internal project meetings; Contribute to global strategy via participation in GRT
- With limited assistance, confirm compliance with applicable regulations and guidelines to ensure suitability of regulatory applications for submission. Provide updates to internal documentation, as appropriate.
- With guidance, provides support to GMP, GCP, and GPV inspections from health authorities.
- With guidance supports pre-approval and post approval activities.
- With guidance maintains relationships with the health authorities, directly or via Affiliate/Partners.
- With guidance manages IMDD, Affiliate, and Partner relationship(s) to ensure efficient global execution.
- At least 3 years of experience within Regulatory Affairs
- Professional skills needed to hold the position:
- General knowledge of the drug development process, of drug regulations, regulatory procedures and drug development guidance
- Effective in verbal and written communication
- Integrity
- Able to work in a matrix and in multicultural teams
- Open and flexible
- Result-driven
- Listen, social intelligent and diplomatic
- Plan & organize
- Good knowledge of regulatory tools for tracking and archiving
- Good knowledge of the basic Office programs
- Ability to prepare PowerPoint presentations
- Ability to search and retrieve information from the worldwide web
- University degree in a scientific discipline, such as Chemistry, Pharmacy, Chemistry and Pharmaceutical Technology, Human Medicine, Biological Science, Biotechnology
- Scientific secondary-school diploma with at least 5 years of experience within International Regulatory Affairs
- Written and spoken English
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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