Global Regulatory Affairs Manager
Chiesi Group
Summary
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.
Job description
Role Overview
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.
Responsibilities
- 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, including authoring, leading, and moderating preparation meetings.
- Accountable for complete and accurate communication/interaction 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.
Qualifications
- 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, 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.
- Proficient in MS Office (Word, Excel, Project), Adobe and ISI Toolbox.
Requirements
- BS/BA in Chemistry, Pharmacy, or Biologic Science
- At least 5 years of research and development experience
- 3 or more years of direct Regulatory Affairs experience
- Knowledge of drug development process, drug regulations, regulatory procedures and guidance
- Able to manage complex tasks and prioritize accordingly
- Effective verbal and written communication
- Strategic thinking and decision making
- Able to work in a matrix and multicultural teams
- Good knowledge of regulatory tools for tracking and archiving
- Good knowledge of basic Office programs
- Ability to prepare PowerPoint presentations
- Ability to search and retrieve information from the worldwide web
- Proficient in MS Office (Word, Excel, Project), Adobe and ISI Toolbox
Benefits
- Comprehensive Healthcare Programs
- Work-Life Balance Initiatives
- Relocation Support
- Performance Bonuses
- Flexible Working Arrangements
- Remote Work Options
- Tax Assistance Services
Company overview
Chiesi Group is a research-oriented international biopharmaceutical company headquartered in Parma, Italy, with over 85 years of experience in the pharmaceutical industry. Founded in 1935 as a family-owned business, Chiesi has grown into a global pharmaceutical group with 31 affiliates worldwide and more than 7,500 employees. The company specializes in developing and marketing innovative therapeutic solutions across three main business areas: respiratory health (AIR), rare diseases (RARE), and specialty care (CARE). Chiesi is particularly recognized for its leadership in respiratory treatments, including inhalers for asthma and COPD, as well as its growing portfolio in rare disease therapies following the acquisition of Amryt Pharma. As a certified B Corporation since 2019 and a Benefit Corporation in Italy, the US, France, and Colombia, Chiesi is committed to sustainable business practices and has set ambitious goals to achieve net-zero greenhouse gas emissions by 2035. The company invests significantly in R&D, allocating over 24% of its revenues to research and development, making it one of the top Italian pharmaceutical companies for R&D investment. With a strong global presence and a focus on patient-centered innovation, Chiesi continues to expand its therapeutic offerings while maintaining its commitment to social and environmental responsibility.