Sr. Manager, Regulatory Affairs

Chiesi USA

Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. More than 7,000 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. 

 

Who we are looking for

Purpose

Develop regulatory strategies for North America region to meet Chiesi GRD Regulatory Affairs relevant objectives, with full responsibility and no need of supervision by the line manager.

#LI-Remote

Main Responsibilities

• In collaboration with consultants, partners and affiliates, plans, coordinate, and manage regulatory submissions to regional agencies throughout the life cycle of GRD products
• Provide advice and guidance regarding regional regulatory requirements on assigned multidisciplinary project teams driving the development and 
  geographical expansion of GRD products
• Contribute to the preparation and/or review of submissions to relevant markets to ensure high quality of the documentation
• Communicate directly with regional regulatory authorities on behalf of Chiesi GRD unit to negotiate strategies and actions associated with regulatory 
  submissions
• Critically review regulatory submission documents, periodic updates, overviews, summaries, etc., makes recommendations for improvement and 
  ensures adequacy for submission
• To be delegated to the development of processes and to the preparation of Standard Operating Documents for GRD Regulatory Affairs, where needed 
• Provide regulatory guidance to colleagues from other functional areas
• Provide regulatory expertise in support of due diligence assessments
• Represent the Regulatory Department at the Core Team as global Regulatory Affairs member, where needed
• With supervision of the line manager, coordinate the preparation of the needed documents for the scientific advice and lead discussions with 
  regional regulatory agencies

Experience Required

• 5-7 years of experience in corporate regulatory affairs roles with an in-depth knowledge of the drug development
• Experience and knowledge in new MAAs and in the life cycle management of registered MAs
• Ability to work independently in the preparation of high-quality submissions and submission documents
• Strong attention to details and quality of the documentation and processes
• Well-developed written and oral communication and listening skills
• Well-developed time management skills and demonstrated ability to manage complex assignments
• Experience in leadership and coaching is an asset
• Well-developed analytical and problem-solving skills
• Ability to work independently and as part of a team

Education

Life Science Degree

Compensation

The annual base pay for this position ranges from $121,000 to $182,000. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. If hired, the employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

What we offer
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, friendl