Regulatory Affairs Director
hace 4 semanas
As a Regulatory Affairs Associate Director at Sandoz, you will lead a team of associates within the Regulatory API department, driving and delivering high-quality documentation to support successful submissions. Your responsibilities will include leading, coaching, and mentoring associates, ensuring sufficient training and development opportunities to maximize regulatory competence. You will also be responsible for financial targets, including cost center responsibility, and ensure timely and accurate reporting of regulatory activities. Additionally, you will analyze group performance, make recommendations for improvement, and coordinate the preparation and execution of regulatory documents. You will formulate and lead global regulatory strategy, focusing on maximizing business benefit while ensuring regulatory compliance. You will also generate, review, and approve internal regulatory guidance documents, protocols, and reports within assigned projects. Your expertise in regulatory guidelines and requirements in global regions and new technical trends will be essential in this role. You will be responsible for transferring knowledge and experiences to the organization and liaising with regulatory agencies, representing the company in regulatory meetings and discussions. You will work according to internal and external guidance, SOPs, and respective timelines. To be successful in this role, you will need a PhD in a natural science field, such as chemistry, pharmacy, or biology, with at least 3 years of work-related post-doctoral or industrial experience, or a Master's or Bachelor's degree in a related field with similar experience. Leadership experience within the regulatory affairs function is also required. You will need broad knowledge of regulatory guidelines, good knowledge of relevant software tools, and good skills in presentation and scientific/technical writing. Fluency in English and Spanish is also essential. If you have a strong background in regulatory affairs and are looking for a challenging role, this could be the opportunity for you. At Sandoz, we are committed to developing and delivering high-quality generic and biosimilar medicines that meet the needs of patients and healthcare professionals.
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Regulatory Affairs Director
hace 3 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoJob Summary:As Regulatory Affairs Associate Director, you will play a pivotal role in driving and delivering high-quality documentation to support successful submissions, ensuring timely and accurate reporting of regulatory activities, and coordinating the preparation and execution of regulatory documents.Key Responsibilities:• Lead, coach, and mentor...
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Regulatory Affairs Director
hace 4 semanas
Barcelona, Barcelona, España Innovaderm Research A tiempo completoThe Senior Manager, Regulatory Affairs will lead the regional regulatory affairs department at Innovaderm Research, ensuring all services are conducted according to standard operating procedures, applicable regulations, and good clinical practices. Key responsibilities include providing leadership on regulatory activities, planning and assigning work,...
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CMC Regulatory Affairs Associate Director
hace 4 semanas
Barcelona, Barcelona, España Az Farmacéutica Spain S.A A tiempo completoJob Title: CMC Regulatory Affairs Associate DirectorAbout the Role: We are seeking a highly skilled CMC Regulatory Affairs Associate Director to join our dynamic team in Barcelona, Spain. As a key member of our cross-functional Regulatory Strategy, Pharmaceutical, and Global Supply Teams, you will collaborate with colleagues across the globe to ensure...
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Regulatory Affairs Associate Director
hace 4 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoJob Summary:As a Regulatory Affairs Associate Director at Sandoz, you will lead a team of regulatory professionals responsible for ensuring compliance with global regulatory standards. Your expertise in regulatory affairs will drive the development and implementation of regulatory strategies to support the company's business goals.Key Responsibilities:Lead a...
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Regulatory Affairs Director
hace 4 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoJob SummaryAs a Regulatory Affairs Associate Director at Sandoz, you will lead a team of associates within the Regulatory API (RAPI) department, responsible for driving and delivering high-quality documentation to support successful submissions within agreed timelines and project plans.Key ResponsibilitiesLead, coach, and mentor associates to ensure the...
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Regulatory Affairs Senior Director of Quality
hace 1 semana
Barcelona, Barcelona, España Sandoz A tiempo completoJob Description: As a Regulatory Affairs Senior Director of Quality, you will lead and manage a team of regulatory professionals within the Regulatory API (RAPI) department, driving the delivery of high-quality documentation to support successful submissions to regulatory authorities. Your key responsibilities include:
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Regulatory Affairs Director for Global Compliance
hace 1 semana
Barcelona, Barcelona, España Sandoz A tiempo completoCompany OverviewSandoz, a leading generics and biosimilars company, is committed to providing high-quality medicines to patients worldwide. With a strong focus on innovation and collaboration, we strive to make a positive impact on people's lives.About the RoleWe are seeking an experienced Regulatory Affairs Director to lead our global compliance efforts....
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Regulatory Affairs Director for Clinical Trials
hace 1 semana
Barcelona, Barcelona, España Innovaderm Research A tiempo completoAbout Innovaderm ResearchInnovaderm Research is a leading organization in the field of clinical trials, and we are seeking an experienced Regulatory Affairs Director to join our team.
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Regulatory Affairs Associate Director for CMC Specialists
hace 2 semanas
Barcelona, Barcelona, España Az Farmacéutica Spain S.A A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Associate Director to join our CMC team in Barcelona, Spain.Key Responsibilities* Provide strategic, tactical, and operational expertise to project teams* Develop creative strategies to support new biological entities and novel products* Collaborate with cross-functional teams to ensure...
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CMC Regulatory Affairs Associate Director
hace 4 semanas
Barcelona, Barcelona, España Az Farmacéutica Spain S.A A tiempo completoJob SummaryAt Az Farmacéutica Spain S.A, we are seeking a highly skilled CMC Regulatory Affairs Associate Director to join our dynamic team in Barcelona, Spain. As a key member of our Regulatory Strategy, Pharmaceutical, and Global Supply Teams, you will play a crucial role in delivering expert CMC regulatory input for projects spanning across the product...
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Regulatory Affairs Specialist
hace 4 semanas
Barcelona, Barcelona, España Galderma Pharma S.A A tiempo completoJob Title:Regulatory Affairs SpecialistGalderma Pharma S.A is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for delivering innovative, breakthrough global regulatory strategies for clinical trial registration with health authorities.The ideal candidate will have a strong...
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Regulatory Affairs Associate Director
hace 4 semanas
Barcelona, Barcelona, España Healthcare Businesswomen'S Association A tiempo completoJob Description SummaryAs a Regulatory Affairs Associate Director at Healthcare Businesswomen'S Association, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high-quality documentation supporting successful submission, within agreed timelines and project plans.Key Responsibilities:Lead, coach, and mentor...
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Regulatory Affairs Specialist
hace 6 días
Barcelona, Barcelona, España Werfen A tiempo completoThe Regulatory Affairs department at Werfen is seeking a highly skilled Quality and Regulatory Affairs specialist to join our team in Barcelona, Spain.As a Quality and Regulatory Affairs specialist, you will be responsible for supporting the execution of pre and post-market regulatory affairs departmental functions. This includes assisting in the preparation...
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Regulatory Affairs Specialist
hace 1 semana
Barcelona, Barcelona, España FARMAPROJECTS SAU A tiempo completoFarmaprojects SAU is a B2B Pharmaceutical Laboratory company offering a broad portfolio of generic pharmaceutical products and value-added medicines. We are looking for a Regulatory Affairs Senior Specialist to join our Regulatory Affairs Department.Key responsibilities include:Developing assessments and strategic regulatory plans for strategic product...
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Regulatory Affairs Specialist
hace 4 semanas
Barcelona, Barcelona, España Sinclair EBD A tiempo completoJob Details: We are seeking a highly skilled Pre-Market Regulatory Affairs Engineer to join our Corporate Regulatory Affairs Team at Sinclair EBD. The successful candidate will be responsible for ensuring regulatory requirements are met for new product development and design changes to established legacy devices.The Role: As a Pre-Market Regulatory Affairs...
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Regulatory Affairs Specialist
hace 4 semanas
Barcelona, Barcelona, España Ramboll Group AS A tiempo completoRegulatory Affairs SpecialistAt Ramboll Group A/S, we are seeking a highly skilled Regulatory Affairs Specialist to join our international Health Sciences service line. As a key member of our team, you will be responsible for providing technical support to clients and colleagues on issues relating to product regulatory compliance and stewardship in Spain.Key...
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Regulatory Affairs Specialist
hace 4 semanas
Barcelona, Barcelona, España Werfen A tiempo completoOverviewWerfen is seeking a Regulatory Affairs Specialist to support the execution of pre- and post-market regulatory affairs departmental functions. The ideal candidate will assist in the preparation of documentation and information required to place and keep products on the market, including regulatory submissions, licensing and registrations. Key...
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Regulatory Affairs Especialista
hace 1 mes
Barcelona, Barcelona, España Uriach A tiempo completo¿Quieres formar parte de nuestro equipo de Regulatory Affairs?Si tienes interés en Regulatory Affairs del sector Consumer Healthcare y eres una persona proactiva, con capacidad de organización y planificación, y rigurosidad, te estamos buscando.Tus responsabilidades:Realizar el registro de los nuevos productos y el mantenimiento de los productos ya...
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Regulatory Affairs Specialist
hace 1 semana
Barcelona, Barcelona, España Dsm Nutritional Products A tiempo completoAt Dsm Nutritional Products, we are looking for a Regulatory Affairs Specialist to join our team in Barcelona. In this role, you will be responsible for providing technical support to the Perfumery and Beauty Documentation team.Key responsibilities include preparing standard documents and basic questionnaires for worldwide customers, using our internal...
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Regulatory Affairs Specialist
hace 1 mes
Barcelona, Barcelona, España Bitfinex A tiempo completoRegulatory Affairs SpecialistBitfinex is seeking a highly skilled Regulatory Affairs Specialist to join our Regulatory and Licensing team. The successful candidate will have a deep understanding of legal and regulatory requirements pertaining to the crypto-asset industry in the Middle East / North Africa region.Key Responsibilities:Develop and execute...