Global Ra Junior Specialist Extra Eu

2 settimane fa

Parma, Italia Chiesi Farmaceutici A tempo pieno

**Date**: Jun 26, 2023

**Department**: Global Regulatory Affairs

**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: 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.

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 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 GRA RA Specialist ensures the execution of regulatory plans in the Region EU & Extra EU for the assigned portfolio.

Main Responsibilities
- Support the Business continuity and GMD strategic plans
- Support the R&D projects cross-functional teams
- Timely inform and coordinate the EU & extra-EU affiliates, other GRA units (operations and CMC), corporate functions (GMD, GPV, GCD, GMA and global MKTG) and external stakeholders (licensors, partners and licensees) for the achievement of the assigned task
- Compile and maintain the regulatory databases

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

Technical Skills
- Good knowledge of the European pharmaceutical legislation, relevant guidelines, procedures and requirements
- Good knowledge of the Extra EU regulatory environment, especially for emerging countries (e.g. China, Brazil, Turkey etc.)
- Consolidated knowledge of the CMC concepts related to Regulatory Affairs
- Good 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
- Good knowledge of the registration dossier (format and content) and the most significant regulatory guidelines (both global and regional)

Soft Skills
Adaptability and flexibility
Emotional and social intelligence
Attention to details
Problem solving
Team working
Communication 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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