Specialist, Regulatory Affairs, Rare Diseases

Descripción del puesto:

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.

We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi Research & Development

Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).

Who we are looking for

Purpose

Join regulatory affairs in Rare Diseases Area! Be part of a dynamic, impactful field where every decision brings life-changing therapies closer to patients in need

Main Responsibilities

* Under guidance of the regional Head, prepares, compiles, and maintains regulatory documents to support a broad range of submissions to regional regulatory authorities within a given timeline.
* In collaboration with consultants, partners and affiliates, plans, coordinates, and manages regulatory submissions to regional agencies throughout the life cycle of Global Rare Disease products.
* Critically review regulatory submission documents, periodic updates, overviews, summaries, etc., makes recommendations for improvement and ensures adequacy for submission.
* Contributes to the development of processes and the preparation of Standard Operating Documents for Global Rare Disease RA.
* Upon request of the manager, provides regulatory guidance to colleagues from other functional areas.
* Prepares responses to questions and/or information requests from regulatory agencies within the timeframes specified.
* Liaises with internal customers, and external customers (e.g., staff at the contract manufacturing organizations, partners, affiliates, and contract research organizations) to request and obtain data relevant to submissions.
* Uses data management systems to track regulatory information pertaining to planned activities and life-cycle management of products.

Experience Required

At least 2 years of experience in regulatory affairs in EU and/or INT at corporate level in a multinational company

Education

Scientific Degree

Languages

Fluent English

Technical Skills

* Experience and knowledge in the life cycle management of regulatory filing.
* Ability to work under supervision in the preparation of high-quality submissions and submission documents.
* Strong attention to details and quality of documents and processes.
* Good knowledge of the basic Office programs

Soft Skills

* Adaptability and flexibility
* Communication skills
* Decision making
* Learning agility
* Planning and organizational skills

Location

Please consider that the position is open to candidates based anywhere in Europe
What we offer

You would join a dynamic, fast-growing, challenging and friendly environment.

In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.

We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.

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