Global Regulatory Project Specialist
Cary, NC, US
Chiesi USA
Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.
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
• Support 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.
• Assist with special projects within Regulatory Operations and Digital as needed.
Experience Required
4 years in Regulatory with good knowledge of drug development and regulatory procedures
• Knowledge of regulatory strategy and dossier development, evidence of successful regulatory operations management
• Strategic planning
• Communication
• Good knowledge of pharmaceutical development
• Good knowledge of process analysis and optimization methods and tools
• Good knowledge of lean six sigma approach
• Innovation and forward thinking
• Make effective decisions
• Plan and execute effectively
• Influence and inspire
• Drive results
• Business knowledge
Education
- At least Bachelor’s Degree in Life Sciences
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals 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 research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
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 transparent ethical behavior at all levels.
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 USA
Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.
What we offer
Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that “Every one of us is different. Every one of us is Chiesi."
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