- University degree in a scientific discipline, such as Chemistry, Pharmacy, Chemistry and Pharmaceutical Technology, Human Medicine
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Global Regulatory Affairs Manager - Cary, NC, United States - Chiesi
Description
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."
Purpose
The Global RA Manager (US Regional Regulatory Lead) contributes to the Company's success by managing the US Regional and in some cases global Regulatory strategy by providing regulatory guidance to the R&D Global Core Team as well as other non-R&D functions.
Main Responsibilities
1) Contributes to company success with collaboration from the Regulatory TA head
2) Accountable for global/regional regulatory strategies for new and existing products in collaboration with the Global Regulatory Team (GRT)
3) Participates in Core Teams as GRT representative
4) Leads according to established best practices
5) Manages and leads the preparation and review of regulatory applications, reports, and correspondence in a manner that ensures timeliness, accuracy, comprehensiveness, and compliance with internal and external regulatory standards, and is a point of contact for FDA for assigned projects and products
6) When required, act as single point of regulatory contact during inspections from health authorities
7) Manages pre-approval and post approval activities, as needed and in agreement within the GRT
8) Maintains relationships with the health authorities, developing in-depth knowledge of relevant regulations and requirements
9) Provides as needed support to Affiliates and Partners for prioritized issues and topics
10) Maintains close relationships with global R&D functions and Franchises; i.e., participates in and manage core team relationships or represent GRT to at Core teams and other cross-functional teams
Global functions:
* Global Clinical Development
* Global Research and Pre-clinical Development
* Chemistry, Manufacturing and Control
* Global Pharmacovigilance
* Project and Portfolio Management
* R&D QA
* Global Manufacturing Division
* Global Marketing
* Global Value & Access
* Global Medical Affairs
* Global Finance
* Global HR
* Information Technology
* Legal and Corporate Affairs
* Corporate Intellectual Property - Patent
* Global Procurement
* Global Rare Disease
* Quality Operations
* Global Strategy & Corporate Development
Experience Required
At least ten years of experience within Regulatory Affairs of which at least five in the international context or direct management of FDA relationships and submissions
Professional skills needed to hold the position
* Specialised skills
* Knowledge of the drug development process, of drug regulations, regulatory procedures and drug development guidance
* Managerial skills
* Lead, influence others and self-motivate
* Able to manage complex tasks and prioritise accordingly
* Effective in verbal and written communication
* Integrity
* Strategic thinking and decision making
* Able to work in a matrix and in multicultural teams
* Open and flexible
* Result-driven
* Listen, social intelligent and diplomatic
* Problem solver
* Manage stress
* Negotiator
* Plan & organise
* Language skills
* Written and spoken English
IT skills
* 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 and other tools
Education
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.
