Regulatory Strategy Associate Director
4 giorni fa
The Regulatory Strategy Associate Director leads global regulatory strategy for complex development programs, providing high-level guidance and representing the company in interactions with health authorities.Main ResponsibilitiesDefine and lead global regulatory strategies for development and marketed products, ensuring alignment with global regulatory lead, corporate objectives and regulatory expectations.Provide strategic input on clinical development plans, including study design, endpoints, and regulatory pathways to optimize approval timelines.Lead preparation and review of major regulatory submissions, including INDs, NDAs, BLAs, MAAs, and post-approval variations, ensuring scientific rigor and compliance.Represent the company in regulatory meetings and negotiations with health authorities, acting as the primary point of contact for strategic discussions.Drive risk assessment and mitigation strategies, anticipating regulatory challenges and developing proactive solutions to minimize impact on timelines and approvals.Mentor and guide junior regulatory staff, fostering professional development and ensuring consistent application of regulatory best practices.Collaborate with senior leadership and cross-functional teams (Clinical, CMC, Safety, Commercial) to ensure integrated strategies and alignment across programs.Monitor global regulatory trends and policy changes, providing strategic recommendations to senior management and influencing internal decision-making.Contribute to process improvements and governance initiatives, ensuring efficiency and compliance in regulatory operations.#J-*****-Ljbffr
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Regulatory Strategy Associate Director
3 giorni fa
Lazio, Italia Jefferson Wells Italia A tempo pienoRegulatory Strategy Associate Director Jefferson Wells Italia is looking for a Regulatory Strategy Associate Director on behalf of an Italian biopharmaceutical company.The candidate leads global regulatory strategy for complex development programs, providing high-level guidance and representing the company in interactions with health authorities.Main...
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Biocides Regulatory Strategy Lead
2 settimane fa
Lazio, Italia Buscojobs IT C2 A tempo pienoThe Director of Regulatory Affairs leads the global regulatory strategy of the MedTech AI Division, ensuring that all software and hardware products (SaMD, AI-enabled real-time systems, edge–cloud devices, imaging platforms, connectivity and data solutions) comply with U.S., EU, and international regulations.Reporting to the VP of Clinical Quality and...
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Associate Director, Regulatory Affairs
2 settimane fa
Lazio, Italia Allergan A tempo pienoCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...
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Associate Director, Regulatory Affairs
2 settimane fa
Lazio, Italia Allergan A tempo pienoCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...
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Lazio, Italia Altro A tempo pienoA leading recruitment agency is seeking a Regulatory Affairs Director in Milan, Italy.The role involves managing a team of Regulatory Line Managers and ensuring compliance with EMEA and FDA regulatory requirements.Candidates should possess over 8 years of experience in regulatory affairs within the medical device industry, with at least 4 years in a...
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Ophthalmology Medical Affairs Associate Director
6 giorni fa
Lazio, Italia Msd Italia A tempo pienoA leading pharmaceutical company in Italy is seeking an Associate Director for Medical Affairs specializing in ophthalmology.This role will involve developing the Medical Affairs strategy, engaging with external stakeholders, and ensuring the implementation of balanced medical education.Candidates must hold an M.D., Ph.D., or Pharm.D.and have a minimum of...
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Director Of Regulatory Advisory
2 settimane fa
Lazio, Italia American Express A tempo pienoA leading financial services company in Rome seeks a Director – Head of Regulatory Advisory to manage regulatory matters and lead a team of specialists.The role requires extensive experience in compliance, particularly within banking.Candidates must have a degree in Law, strong leadership skills, and be fluent in Italian and English.This position offers a...
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Hazloc Regulatory Knowledge Associate
3 giorni fa
Lazio, Italia Ul Solutions A tempo pienoA global leader in safety science is seeking a Knowledge Associate specializing in Hazardous Locations in Carugate, Italy.This entry-level position involves regulatory research and guidance on compliance standards to facilitate product access to international markets.Candidates should have a high school diploma, with 2 years of experience preferred, and...
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Associate Director Quality Assurance
11 ore fa
Lazio, Italia Altro A tempo pienoOverviewWe are seeking an experienced and forward-thinking Associate Director of Quality Assurance to join our growing pharmaceutical organisation and lead key Quality Operations across GMP manufacturing.In this role, you will oversee the continuous improvement of our Quality Management System, ensuring full compliance with global regulatory requirements (EU...
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Lazio, Italia Altro A tempo pienoDirector, EMV 3DS Product Management, Europe Join to apply for the Director, EMV 3DS Product Management, Europe role at Mastercard Our Purpose: Mastercard powers economies and empowers people in 200+ countries and territories worldwide.Together with our customers, we're helping build a sustainable economy where everyone can prosper.We support a wide range of...
