Senior Global Regulatory Affairs Project Manager
Parma, IT
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 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: 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, 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).
Who we are looking for
Purpose
Support planning, execution and follow-up of timelines and resources for GRA regulatory filings through product development and life-cycle management
Main Responsibilities
Project Coordination
- Collaborate with Operational Excellence team members to execute regulatory project coordination and management, including agile ways of working, within GRA utilizing common templates and project plans.
- Support the Therapeutic Areas (TAs) by assisting with the management, and tracking of specific deliverables within GRA, including but not limited to INDs, NDAs, BLAs/MAAs and major variations, working with cross-functional teams.
- Align with Project and Portfolio Management (PPM) to identify key milestones for GRA to meet business objectives, from clinical trial initiation, regulatory submission, approval, and post-approval life cycle management.
- Support internal initiative(s) with a goal to accelerate internal regulatory processes and subsequently development timeline
- In collaboration with the GRA Global Regulatory Leads and/or the GRA Regulatory Managers and Specialists, support the following activities:
o Track GRA project related costs to ensure alignment with overall project budgets.
o Ensure roles and responsibilities within submission teams are clearly defined.
o Cross functional submission team meetings to drive decision making and project execution; help in the creation of agendas, meeting minutes, and tracking/resolution of action items.
- Ensure overall GRA project timelines are aligned cross-TA / cross-functional teams and support the coordination of timely regulatory submissions.
- Identify and recommend solutions for timeline concerns or obstacles, including risks and issues, engaging appropriate leads for mitigation and resolution.
- Coordinate projects which impact more than one TA; setting up and leading cross-TA / cross-functional teams as applicable
- Assist with special projects within Regulatory Operations and Digital as needed.
Experience Required
5 years in Regulatory with good knowledge of drug development and regulatory procedures
Education
At least Bachelor’s Degree in Life Sciences
Languages
Fluency in english
Technical Skills
Knowledge of regulatory strategy and dossier development, evidence of successful regulatory operations management
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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