Sr. Manager, Regulatory Affairs

Chiesi Group

16d • Remote

About The Position

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 forPurposeDevelop 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.
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Requirements

• 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
• Well-developed analytical and problem-solving skills
• Ability to work independently and as part of a team
• Life Science Degree

Nice To Haves

• Experience in leadership and coaching is an asset

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

Benefits

• 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.
• We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.
• 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, marital status, veteran status, 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level