Manager, EU & International Regulatory Affairs, Global Rare Diseases
Job Description & How to Apply Below
Department: GRD Regulatory Affairs
Business Area: R&D, Pharmacovigilance & Regulatory Affairs
Job Type: Direct Employee
Contract Type:
Permanent
Location:
Parma or Dublin, IT
About us
Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. 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 and inclusion 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.
This is what you will do
Reporting to the Lead, EU & Int'l Regulatory Affairs, Global Rare Diseases, the Manager, EU & International Regulatory Affairs develop regulatory strategies for EU & International markets to meet Chiesi Global Rare Diseases Regulatory Affairs relevant objectives.
You will be responsible for
In collaboration with consultants, partners and affiliates, plan, coordinate and manage regulatory submissions to regional agencies throughout the life cycle of GRD products
In full alignment with the Lead, EU & Int'l Regulatory Affairs, Global Rare Diseases, provide advice and guidance regarding regional regulatory requirements driving the development and geographical expansion of GRD products
Contribute to the preparation and/or review of submissions to relevant markets to ensure the high quality of the documentation
In agreement with the Lead, EU & Int'l Regulatory Affairs, Global Rare Diseases, communicate directly with regional regulatory authorities on behalf of Chiesi GRD to negotiate strategies and actions associated with regulatory submissions
Critically review regulatory submission documents, periodic updates, overviews, summaries, etc., make recommendations for improvement and ensure adequacy for submission
Contributes to the development of processes and the preparation of Standard Operating Documents for GRD Regulatory Affairs
In full alignment with the Lead, EU & Int'l Regulatory Affairs, Global Rare Diseases, 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 a global RA member, where needed
Support the Lead, EU & Int'l Regulatory Affairs, Global Rare Diseases in the preparation of the needed documents for the meetings and interactions with regional regulatory authorities
You will need to have
3 to 5 years of experience in corporate regulatory affairs roles with an in-depth knowledge in drug development
Life Science degree(s)
Flexible, collaborative, open minded
Well-developed written and oral communication and listening skills
Time management skills and demonstrated ability to manage…
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