Global Regulatory Affairs Manager
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About Us
Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.
At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
Diversity, inclusion, and equal opportunity are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.
Chiesi Global Rare Diseases
Chiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available.
This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma.
Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here.
Who we are looking for
This is what you will do
This position contributes to the company success by serving as core member of Global Regulatory Team (GRT) and strategic partner to the Global Regulatory Lead (GRL), defining and executing global regulatory strategy to deliver business objectives. Supports global regulatory strategy execution for assigned regions, ensuring Target Product Profiles (TPPs) align throughout development and lifecycle management.
You’ll be responsible for:
- May serve as a regional/local regulatory lead and point of contact both internally and with Health Authorities.
- Contributes (independently or with GRL/ Manager guidance) to the development of global HA interaction strategy in collaboration with GRT members
- Develops Health Authority engagement and interaction plans for assigned products, independently or with GRL/manager guidance, including authoring, leading, and moderating preparation meetings.
- Accountable for complete and accurate communication/interaction (including tracking in relevant systems) with the HAs, affiliates and IMDD partners for assigned projects/products.
- Leads regulatory subteams to deliver NDA/BLA/MAA/Extension/Variation/Renewal filings on time and develops core global dossiers with Project Managers and GRT members.
- Ensures that regulatory submission timelines are aligned with program level and company objectives.
- Contributes to content and reviews of regulated documents
- Supports operational and compliance activities for assigned deliverables.
- Supports GMP, GCP, and GPV inspections from health authorities.
- Provides updates on project and submissions status to GRT members
- Supports the GRL on updates to the Affiliates and interactions with IMDD and partners.
- Actively contribute to the sustainability goals to further the impact on patients, customers, employees, community and the planet by demonstrating a shared value mindset.
You will need to have
- BS/BA in Chemistry, Pharmacy, or Biologic Science. Graduate degree preferred
- At least 5 years of research and development experience, including 3 or more years of direct Regulatory Affairs experience
- Knowledge of the drug development process, of drug regulations, regulatory procedures and drug development guidance; Regulatory Affairs Certification highly preferred
- Able to manage complex tasks and prioritize accordingly
- Effective in verbal and written communication
- Strategic thinking and decision making
- Able to work in a matrix and in multicultural teams
- 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
- Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining high attention to detail while responding to rapidly changing priorities and aggressive deadlines.
- Proficient in MS Office (Word, Excel, Project), Adobe and ISI Toolbox.
Location
Hybrid position based in Cary, NC.
No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.