Life-cycle Management and Regulatory Compliance

3 giorni fa

Parma, Italia Chiesi Farmaceutici A tempo pieno

**Department**: Global Regulatory Affairs
**Team**: R&D, Pharmacovigilance & Regulatory Affairs

**Job Type**: Direct Employee
**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: 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, chemical manufacturing and controls, 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) and Toronto (Canada).

Who we are looking for

Purpose

The Regulatory Affairs Life-Cycle Management Unit Specialist is in charge of managing regulatory aspects of projects intended for lifecycle management of approved Marketing Authorisations. This includes preparing and maintaining dossier documentation for licence variations in all the Region “China and International”.

Main Responsibilities
Gap analysis of approved dossiers (quality and clinical sections)
Revision and assessment of change control requests pertaining to CMC aspects of products. Follows through with necessary submissions and actions required in support of the implementation of the changes
Preparation, submission and follow-up of quality and clinical variations to existing Marketing Authorisations (MAs) in all the Region “China and International”
Determine, from a strategic and scientific perspective, the technical needs to support regulatory procedures to be submitted to regulatory agencies
Experience Required
At least three years of experience within Regulatory Affairs, in the international context
Experience within RA for Extra EU countries will be a plus
Education
University degree in a scientific discipline, such as Chemistry, Pharmacy, Chemistry and Pharmaceutical Technology, Human Medicine, Biological Science, Biotechnology
Regulatory Affairs Certification or a diploma from an RA program is an asset
Languages
Fluent English
Spanish welcome (for Latin America)
Technical Skills
Good knowledge of the International regulatory environment
Good knowledge of the CMC concepts related to Regulatory Affairs
At least basic knowledge of the main pre-clinical and clinical concepts related to Regulatory Affairs
Good knowledge and understanding of CMC drug development (general concepts), both global and regional
Very good knowledge of the registration dossier (format and content) and the most significant regulatory guidelines (both global and regional)
Soft Skills
Attention to details
Communication skills
Conflict management
Creative/innovative mindset
Goal orientation
Planning and organizational skills
Quality orientation

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 JOB OPPORTUNITIES
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