**Department**: International Markets Development Division
**Job Type**: Direct Employee
**Team**: R&D, Pharmacovigilance & Regulatory Affairs
**Contract Type**: Permanent
**Location**:
Parma, IT
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 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.
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.
We are committed to embrace diversity, inclusion and equal opportunities.
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 CCO - Commercial Organization
Following the continued growth of the Company and the increasing portfolio complexity, Chiesi decided to introduce the Chief Commercial Officer (CCO) role and organization.
The new organization is a truly global operating model, ensuring a uniform approach across all geographies (30 affiliates worldwide).
The CCO Organization includes Global Marketing, Global Medical Affairs, Global Value & Access and all the commercial functions of every affiliate.
Who we are looking for
Purpose
This position will support the Regulatory Affairs Manager by operating in relation to well-established products (as included in the life cycle management and global expansion team, where R&D Core Teams are not set), by performing the regulatory assessment in cooperation with the relevant local partners in the required IMDD countries and by verifying the related registration feasibility, business opportunities and costs impact.
You will also support the maintenance of the product licenses held by the company for well-established products in the IMDD countries and ensure that registrations are kept up to date with the relevant Regulatory Authorities.
Finally, he/she will also provide support to the Regulatory Affairs Manager for other IMDD activities where a regulatory imput is requested.
Main Responsibilities
**For well-established products**:
You will support the preparation of responses to questions raised by the Regulatory Authorities.
You will follow up with Regulatory Authorities on regulatory issues.
Education
A science-based degree or equivalent (Ideally CTF, Pharmacy, Chemistry or Biology related) matched with economical know-how is essential as there is a requirement to gain a sound technical understanding of clinical and manufacturing/quality aspects of the company products in addition to a business sense.
Experience Required
Regulatory background (3 years as a minimum), with a good working knowledge of all the processes, legislative procedures and dossier format (e.g.
eCTD) that need to be adhered to by a pharmaceutical organization for the licensing of medicinal products.
Previous experience with clinical variations impacting the product PI is considered a plus.
Previous experience in extra-EU countries is considered a plus.
Languages
Fluent in English both written and spoken
Technical Skills
Knowledge of the drug dossier structure is essential (e.g.
CTD)
Sound understanding of common regulatory procedures
Good organizational skills for planning and keeping track of multiple activities while meeting the timelines requested by local authorities
Soft Skills
Attention to details
Analytical skills
Communication skills
Planning and organizational skills
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.
Discover all our opportunities
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