Senior Global Regulatory Affairs Cmc Manager Parma

Senior Global Regulatory Affairs Cmc Manager
Parma
Emilia Romagna, Parma

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Senior Global Regulatory Affairs CMC Manager Date: 3 Feb 2025

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 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.

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).

Purpose Pursuing and executing global, robust and innovative Regulatory-CMC strategies, across the entire life-cycle with focus on Marketing Authorization Application but generally on all phases (mainly 1-3 of development, but also pre-clinical and post-approval activities) of global products and projects, primarily on chemically synthetized DS, DP as well as medical devices (including the device component of combination products).

Competence on inhalation products is an important part of profile.

Ensuring appropriate analyses and sharing of CMC regulatory internal and external information/intelligence and active participation in commenting on regulatory-CMC related topics.

Competence on Biologics is a plus.

Main Responsibilities Accountable and Responsible, for drug products Regulatory-CMC strategy development and Quality regulatory documents (Quality-IMPD/IND, Quality part of Briefing Documents, M2. 3, M3, ) preparation, writing and management.

Be the Regulatory-CMC representative or leader to Regulatory and Project meetings.

Provide input and expertise for the definition and execution of Regulatory-CMC standards and procedures (SOPs).

Provide regulatory assessment of Change Control, preparing and giving CMC-RA relevant input on CMC related Development and Life-cycle documents.

Check international regulatory websites to proactively verify Guidelines (ICH, EMA, FDA & other).

Experience Required About 5/6 years of experience in global Drug Regulatory CMC and CMC Development and the adjacent CMC areas (analytical, manufacturing process, stability etc).

Education Bachelor's Degree in Chemistry and Pharmaceutical Technology, Chemistry (or Biology, Biotechnology).

Advanced degree (M. Sc/ PhD) in a related discipline is a plus.

Languages Technical Skills Knowledge of the full drug development process.

Knowledge of global drug legislation, regulatory procedures and drug development guidelines.

Ability to navigate through different quality-CMC regulatory requirements.

Understanding of technical aspects is a plus (ex: analytical methods for Inhalation Drug product analysis and characterization, manufacturing processes etc).

Soft Skills Adaptability and flexibility Decision making Goal orientation Leadership and social influence Location The role can be based in Europe, preferably where an R&D center is located (Italy, UK, France and Sweden)

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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