Manager, US Regulatory Affairs R&D - Pipeline


Cary, NC, 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 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."



Contribute to the Company’s success by providing regulatory guidance to the global R&D Core Team.


Main Responsibilities

Regulatory Affairs Strategy and Management: 
•    Participate in R&D Core Teams (CTs) and Global Regulatory Teams (GRTs).
•    Oversee annual budgeting for regulatory activities and manage activities against approved budget
•    Organize and lead cross functional Regulatory subteams to meet business objectives
•    Counsel and advise on regulatory procedures consistent with disease area and available guidelines
•    Develop and manage multiple and possibly conflicting complex projects, timelines, and objectives within a matrix team environment
•    Provide detailed review of project documents to ensure technical accuracy and compliance with regulatory requirements
•    Serve as FDA point of contact for assigned assets.
•    Provide leadership and planning for meetings with FDA. 
•    Contribute regulatory perspective due diligence evaluations of potential acquisitions and partnerships
•    Provide knowledgeable support to the production and management of product labelling, promotional material, and risk mitigation strategies
•    Support regulatory compliance of clinical trials by providing guidance on applicable regulations and FDA/ICH guidelines and standards
•    Compile comprehensive scientific information for use in regulatory submissions
•    Manage and lead the preparation and review of US regulatory applications, reports, and correspondence in a manner that ensures timeliness, accuracy, comprehensiveness, and compliance with internal and external regulatory standards
•    Act as point of contact and primary regulatory resource for internal and external technical file (e.g., IND, NDA, BLA, etc.) audits
•    Ensure maintenance of technical files as necessary to obtain and sustain product approval
•    Performs other related duties as assigned.
Regulatory Affairs Information and Intelligence: 
•    Maintains current knowledge of relevant regulations, including proposed and final rules. 
•    Evaluates impact and analyses trends of FDA regulatory developments and interpret essential elements for impact on strategic regulatory decisions.
•    Monitor competitor products and their submission outcomes for potential impact on the regulatory strategy.
•    Manage, promote, and circulate relevant regulatory information on projects/products applicable to the R&D pipeline by means of meetings, databases, and/or intranet.
•    Recommend changes to company procedures in response to changes in regulations or standards.

Experience Required

Experience in the Pharmaceutical industry: 8+ years
•    Direct Pharma Regulatory experience: 5+ years
•    In-depth knowledge of the full drug development process inclusive of direct experience with FDA meetings and submissions for new drugs and biologics performed in accordance with US/FDA laws and regulatory procedures
•    Proficiency in reading and interpreting regulatory guidance documents and initiating changes in systems to ensure regulatory compliance
•    Understanding of US federal regulations and processes related to the development of drugs and filing of an application
•    Demonstrated proficiency in written, verbal and face-to-face communication skills with ability to effectively present information and influence decision making of working partners (local and global) and government agencies
•    Proven ability to manage multiple tasks and multifunctional resources concurrently and to respond to rapidly changing priorities and aggressive deadlines
•    Expertise in technology systems utilized for electronic documentation, including but not limited to: Microsoft Office, Acrobat Professional, eCTD Viewer


  • BS/BA in Chemistry, Pharmacy, or Biologic Science. Regulatory Affairs Certification preferred

Technical Skills

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.