Regulatory Affairs Specialist Extra Eu - Manchester, United Kingdom - Chiesi Farmaceutici

Chiesi Farmaceutici

Verified Company

Manchester, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Regulatory Affairs Specialist extra EU

Date:
Feb 17, 2023

Department:
Global Regulatory Affairs

Job Type:
Direct Employee

Team:
R&D, Pharmacovigilance & Regulatory Affairs

Contract Type:
Permanent

Location:

Manchester or anywhere in UK, GB

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 Regulatory Affairs Neonatology and Special Care Unit Junior Specialist provides support to the Regulatory Affairs Neonatology and Special Care Unit Head for the Region China & International for development, registration, and approval/post-approval of drug products, medical devices and food supplement.

Main Responsibilities

The Regulatory Affairs Neonatology and Special Care Unit Junior Specialist supports the execution of local regulatory plans in line with Global Regulatory Strategy under the supervision of the Regulatory Affairs Unit Head.

Support the R&D projects cross-functional teams;
Timely inform and coordinate the Affiliates/Partners, 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

Provides the Regulatory Affairs Unit Head with support on identification of gaps or risks in the Regional part of global strategic plan, the overall regulatory planning for the Area (MA Applications, renewals and transfers of MA), in agreement with the strategies to meet market priorities and necessary maintenance of existing MAs.

Compile and maintain the regulatory databases.

Submissions and Approvals:
Supports the integration of Global Strategy into submissions
Contributes to identification of gaps affecting timely submission and approval
Facilitate preparation and submission of Response Documents
Supports the implementation plans for timely response to HA requests and supports coordination of responses
Experience Required

At least 1-3 years of experience in a pharmaceutical company preferably in Regulatory Affairs for extra EU Countries

Education

Degree preferably in MSc or equivalent

Languages

Fluent English (Spanish and/or French is a plus)

Technical Skills
Basic knowledge of the European & Non-European pharmaceutical legislation, relevant guidelines, procedures and requirements.
Basic knowledge of the registration dossier (format and content) and the most significant EU & Non-EU guidelines
General knowledge and understanding of drug development (general concepts)
Soft Skills
Adaptability and flexibility
Continuous learning
Emotional and social intelligence
Problem solving
Team working

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 imp