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Global Head of Regulatory Affairs, Rare Diseases

Company: Chiesi USA
Location: Raleigh
Posted on: September 13, 2020

Job Description:

Current job opportunities are posted here as they become available.

Chiesi is committed to helping each and every team member develop professionally and contribute to our extraordinary goal of changing patients’ lives. We believe the team always accomplishes more than the individual and that the success of our company depends on the growth and achievement of every single member.

In compliance with local, state, national and federal disability laws world-wide, we would be happy to reasonably accommodate any disability needs in support of the application process. If you are an individual with a disability that requires a reasonable accommodation or are unable or limited in your ability to use or access our recruitment tool as a result of your disability, you can request reasonable accommodations in the recruitment process by calling (888) 466.6505  or sending an email to us.jobs@chiesi.com .

Below is a list of the current openings with our company. Click on the job title to learn more about the opening.

Global Head of Regulatory Affairs, Rare Diseases Company Mission: We want to revolutionize the lives of people living with rare diseases by providing an integrated set of definitive solutions. The patients are the beginning and the end of our journey. For them, we work in close partnership with patients, caregivers, patient associations, healthcare practitioners, regulatory and pricing authorities.

We intend to maintain a high-quality entrepreneurial team, characterized by a spirit of cooperation and self-confidence. Our goal is to combine commitment to results and integrity while operating responsibility from both a social and environmental point of view.

Purpose: The Global Rare Diseases Regulatory Affairs Head will be responsible for heading, leading and managing the Regulatory Affairs department for rare disease products in development and after approval with a global scope. The Global Rare Disease (GRD) Regulatory Affairs department is the functional area defining and implementing the regulatory strategy and functional plan for all products managed by GRD at global level, during the development phase and the product life-cycle management after approval, including the relationship with regulatory agencies of major geographies, with the Regulatory Affairs department of Chiesi affiliates, and with the Global Regulatory Affairs group (accountable for all non-rare regulatory activities).

This position will be based in either Cary, NC or Boston, MA.

RESPONSBILITIES:

Will build and manage a global team in the US, Canada and Italy. Departmental responsibilities :

o Regulatory strategy and execution for products in development (including initial registration in US/ EU/ UK)

o Relationship/ correspondence with key regulatory agencies o MA maintenance and variations post-approval

o Geographical expansion beyond initial registrations o Liaison with affiliates/ partners

o Relationship with Global Regulatory Affairs (the Chiesi Group function for non-rare regulatory affairs)

o Build-up and maintenance of infrastructure (systems, processes, e-publishing)

Will build the GRD Regulatory Affairs function, including organizational design/development, recruitment, onboarding, and the creation of the management system and of the department infrastructures in line with Chiesi policies and existing shared resources for document and regulatory management.

Will lead and manage the global regulatory department: budget and resource allocation, staff supervision and oversight (recruitment, development, performance management, delegation of responsibilities), assessing and improving departmental policies and procedures.

Defining regulatory policies and strategies for GRD in agreement with the overall Regulatory Affair policies of the Chiesi group

Securing high-profile relationship with the concerned institutional authorities · Providing high-level counseling and expertise to the strategy of GRD R&D

Being part of the GRD R&D leadership team

Ensuring an effective, up to date and constant information is shared across the Group's Companies and Functions about all the changes, evolutions and perspectives of the international laws and regulations impacting on development, registration, promotion and distribution of rare disease drugs.

Representing Chiesi Rare Diseases in international and public affairs environments related to regulatory affairs

REQUIREMENTS

· 10+ years of experience in regulatory affairs

· Significant level of understanding of regulatory science and key requirements on a global scale, in particular:

o Significant understanding of US regulatory affairs and material experience in interacting with FDA

o General understanding of the EU regulatory system and possibly experience in working with EMA

o High-level understanding of regulatory requirements in other geographies (e.g. Japan)

· Relevant experience in rare disease product development and in expedite development programs in US and EU.

· Experience in the development of biotechnology products.

· Understanding of life-cycle management requirements for rare disease products.

· Capability to work with remote, geographically-distributed, international teams.

Keywords: Chiesi USA, Raleigh , Global Head of Regulatory Affairs, Rare Diseases, Other , Raleigh, North Carolina

Click here to apply!

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