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Global Reg-Cmc Sr. Specialist
3 mesi fa
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.
Who we are looking for PurposeAccountable for:
• Pursuing and executing global, robust and innovative Regulatory-CMC strategies, across the entire life-cycle (pre-clinical, clinical, life-cycle and change management) of Chiesi global products and projects, intended as chemically synthetized or biologics DS, DP, medical devices (including the device component of combination products).
• Acting as GRA representative or leader for CMC topics in the project teams to ensure proper planning and communication as well as to support decision-making.
• Writing of Internal Reg CMC WI/SOP, revision or contribution to GRA or Company documents involving Reg CMC.
• Ensuring appropriate analyses and sharing of CMC regulatory external information/intelligence and active participation in commenting for regulatory-CMC related topics.
• Contributing, as active member of the GRA-CMC LCM Unit, to promote collaboration, communication and the continuous growth in terms of efficiency and excellence, ensuring alignment in the execution, proactive sharing of experience and development of proposals for possible new ways of working.
• Building and maintaining relationships within and outside GRA, specifically Global Technical Development (GTD), Global Manufacturing Division (GMD), Global Rare Disease Unit (GRD) and Extended Teams.
Main Responsibilities• Regulatory-CMC representative or leader to Regulatory and Project meetings in alignment with Omnis model.
• Independently provides input and expertise for the definition and execution of Regulatory-CMC standards and procedures (including writing of GRA-CMC WIs, SOPs, Tools).
• Accountable, across the entire drug products life-cycle, for Regulatory-CMC strategy development and Quality regulatory documents preparation, writing and management.
• Independently provide regulatory assessment on Change Control, preparing CMC related Development and Life Cycle change management documents.
• Independently interacts with external and internal stakeholders.
• Contributes on collection, analyses, comment and sharing for external regulatory-CMC intelligence and information.
• Provide regulatory CMC review and input to other departments processes and/or documents (i.e. SOPs, Specification Committee, Device documents).
• Provides a specific contribute on identified quality specific areas as Subject Matter Expert.
Experience RequiredIndicatively 5-to-8 year experience in global drug Regulatory CMC and CMC Development.
Detailed experience of drug development, manufacturing, and supply processes within the pharmaceutical industry.
Demonstrated experience in handling complex global CMC issues through continuous change and improvement.
EducationAt least Bachelor's Degree in Chemistry and Pharmaceutical Technology, Pharmacy, Chemistry, Biology or similar.
LanguagesTechnical SkillsExtensive knowledge of the full drug development process. High-level knowledge of global drug legislation, regulatory procedures and drug development guidelines. Ability to navigate through different quality regulatory requirements.
Soft SkillsAdaptability and flexibilityEmotional and social intelligenceStrategic thinkingWhat 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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