Regulatory Affairs Senior Specialist
Há 2 dias
At Biom?Rieux Bv, we are seeking a highly skilled Regulatory Affairs Senior Specialist to join our team. This role is responsible for implementing regulatory strategies for assigned products in accordance with global regulations and guidelines. The ideal candidate will have a strong background in chemistry, manufacturing, and controls (CMC) and be proficient in English.
Job Summary
We are looking for a motivated and experienced Regulatory Affairs Senior Specialist to support the preparation and review of information required for development of regulatory CMC dossiers for life-cycle maintenance submissions and post-approval changes. The successful candidate will provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation.
Main Responsibilities:
- Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation.
- Execute global regulatory strategies by leading the development, authoring, and review of CMC submission components and documentation to support post-approval supplements and responses to health authority questions.
- Ensure product compliance through timely and accurate maintenance of CMC submissions in the systems.
- Liaise with our Company's Manufacturing & Supply colleagues and external partners to support compliant execution of change management.
- Assess and communicate potential regulatory risks and propose mitigation strategies.
- Deliver all regulatory milestones for assigned products across the product lifecycle.
- Identify and communicate potential regulatory issues to our company's Regulatory CMC management, as needed.
Requirements:
- Bachelor's degree in a science, engineering, or related scientific field with at least four years of overall relevant work experience.
- Advanced degree (MS, MBA, Ph.D., PharmD) in a science, engineering, or related scientific field with at least two years of overall relevant work experience.
- Minimum of two (2) years of relevant CMC experience, including biological/pharmaceutical research; manufacturing, testing, or a related field.
- Proficient in English; additional language skills are a plus.
- Familiar with regulatory guidelines for product post-approval change management and data requirements.
- Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner.
Salary:$120,000 - $150,000 per year, depending on experience
This is a full-time position based in [location]. We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.
At Biom?Rieux Bv, we value diversity and inclusion. We are an equal opportunity employer and welcome applications from candidates with diverse backgrounds.
-
Regulatory Affairs Advocacy Specialist
2 semanas atrás
Lisboa, Lisboa, Portugal Mastercard Tempo inteiroCompany OverviewMastercard: Connecting the World Through Innovative Payments SolutionsWe are a global technology company in the financial services industry, operating the world's fastest payments processing network. Our mission is to make transactions safe, simple, smart and accessible for everyone, everywhere.SalaryThe estimated annual salary for this...
-
Regulatory Affairs Professional
4 semanas atrás
Lisboa, Lisboa, Portugal Abbvie Tempo inteiroRole OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at AbbVie. This role will be responsible for maintaining Marketing Authorisations and Medical Devices registrations, ensuring compliance with local legislation and corporate requirements.About the JobThis position is focused on providing regulatory support for the...
-
Regulatory Affairs Director
Há 2 dias
Lisboa, Lisboa, Portugal Mygwork Tempo inteiroTransformative Opportunity in Regulatory AffairsThis is a pivotal role at Thermo Fisher Scientific, an inclusive employer and a member of the LGBTQ+ business community. We're seeking an experienced Senior Manager to lead our Regulatory Affairs team in Europe.About the JobAs a Senior Manager of Regulatory Affairs, you will be responsible for ensuring...
-
Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiroJob DescriptionThe PositionBiom?Rieux Bv is seeking a skilled Regulatory Affairs Chemistry Manufacturing Senior Specialist to provide regulatory CMC support for Organon Network Projects. This position will lead the preparation and submission of CMC dossiers for assigned Network Projects, while working alongside CMC Product Leaders, OMS Network Teams, and CMC...
-
Regulatory Affairs Professional
Há 1 mês
Lisboa, Lisboa, Portugal Adecco Tempo inteiroRegulatory Affairs SpecialistAre you an EU Market Regulatory Affairs expert looking for a new challenge in the pharmaceutical sector? We have a fantastic opportunity for you!Key Responsibilities:Handling of all post-approval activities related to ANDAs, MAAs, ANDSs, variations/supplements, Annual Reports and deficiency letters according to regulatory...
-
Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiroAbout the RoleWe are seeking a Clinical Trial Regulatory Affairs Specialist to join our global Regulatory Affairs department – Regulatory Science team. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting.Job DescriptionIn this role, you will be a pivotal team member with regulatory...
-
Regulatory Affairs Expert for EU Pharmaceutical Sector
1 semana atrás
Lisboa, Lisboa, Portugal Buscojobs Portugal Tempo inteiroSenior Regulatory Specialist Role in Sintra, PortugalWe are seeking a highly experienced and skilled regulatory affairs specialist to join our team in the pharmaceutical industry based in Sintra, Portugal.Job Summary:The ideal candidate will have extensive knowledge of EU market regulations and experience in handling post-approval activities related to...
-
Senior Regulatory Affairs Specialist
Há 1 mês
Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiroJob Description:At Biom?Rieux Bv, we are seeking a highly skilled Sr. Scientist, Regulatory Affairs to join our team. The ideal candidate will have a strong background in regulatory chemistry, manufacturing, and controls (CMC) and be able to develop and implement global regulatory strategies for assigned products.Key Responsibilities:Develop and execute...
-
Regulatory Affairs Lifecycle Process Specialist
2 semanas atrás
Lisboa, Lisboa, Portugal Adalvo Tempo inteiroAdalvo, a dynamic and fast-paced company based in Portugal, seeks an exceptional Regulatory Affairs Lifecycle Process Specialist to join its team. Job SummaryThe successful candidate will be responsible for ensuring compliance with applicable laws, regulations, and guidelines to facilitate the approval of all post-approval activities of products.About the...
-
Regulatory Affairs Specialist
Há 2 dias
Lisboa, Lisboa, Portugal The British American Tobacco Group Tempo inteiroOverviewThe British American Tobacco Group is evolving at pace into a global multi-category business, aiming to decrease the health impact of our industry. To achieve this ambition, we seek experienced professionals who are ready to make a positive impact. Our External Affairs Manager role in Portugal offers a unique opportunity to work on high-profile...
-
Regulatory Affairs Expert
Há 1 mês
Lisboa, Lisboa, Portugal Phiture Tempo inteiroJob OverviewWe are seeking a Regulatory Affairs Specialist to join our team at AbbVie. The successful candidate will be responsible for ensuring the maintenance of Marketing Authorisations and Medical Devices registrations.Key Responsibilities:Maintain Marketing Authorisations and Medical Devices registrations through variations and other regulatory...
-
Regulatory Affairs Specialist
4 semanas atrás
Lisboa, Lisboa, Portugal Buscojobs Portugal Tempo inteiroCompany OverviewA leading pharmaceutical company in Sintra is seeking a skilled Regulatory Affairs Specialist to join their team.Estimated SalaryThe annual salary for this role is approximately €60,000, considering the industry standards and location.Job DescriptionThis role involves handling all post-approval activities related to Abbreviated New Drug...
-
Lead Medical Devices Specialist
4 semanas atrás
Lisboa, Lisboa, Portugal SGS Tempo inteiroAbout the RoleWe are seeking a highly experienced Lead Medical Devices Specialist - Regulatory Affairs to join our team at SGS. This is an excellent opportunity for a skilled professional to take their career to the next level and make a significant impact in the field of certification.
-
European Regulatory Affairs Specialist
Há 21 horas
Lisboa, Lisboa, Portugal Phiture Tempo inteiroAbout the RoleWe are seeking a skilled European Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Excellence group, you will play a crucial role in ensuring the continuous improvement of end-to-end processes and driving proactive solutions for automation, digitalization, and simplification.Key ResponsibilitiesMaintain and...
-
Regulatory Affairs Specialist for Consumer Healthcare
2 semanas atrás
Lisboa, Lisboa, Portugal Haleon Tempo inteiroAt Haleon, a world-leading consumer health company, we're shaping the future of everyday health. Our mission is to improve the lives of billions of people by growing and innovating our global portfolio of category-leading brands. As a Regulatory Affairs Officer, you'll play a crucial role in ensuring compliance with laws and regulations, facilitating smooth...
-
Regulatory Affairs Specialist: Global Labeling Expert
3 semanas atrás
Lisboa, Lisboa, Portugal PharmaLex Tempo inteiroJob DescriptionWe are seeking a highly experienced Regulatory Affairs Specialist to join our team at PharmaLex. This is a challenging opportunity for an individual who possesses in-depth knowledge of regulatory affairs, particularly in the area of labeling.About the RoleIn this role, you will be responsible for preparing and revising labeling documentation...
-
Regulatory Affairs Director
2 semanas atrás
Lisboa, Lisboa, Portugal Mygwork Tempo inteiroCompany Overview: Thermo Fisher Scientific is an inclusive employer and a member of myGwork, the largest global platform for the LGBTQ+ business community. As a leading life sciences company, we strive to make a positive impact on a global scale.Estimated Salary Range: $120,000 - $180,000 per annum, depending on experience.Job Description: We are seeking a...
-
Regulatory Affairs Professional
3 semanas atrás
Lisboa, Lisboa, Portugal Buscojobs Portugal Tempo inteiroBuscojobs Portugal is seeking an experienced Regulatory Affairs Specialist to join our client company in Sintra. This role offers a direct contract with the client, an adequate salary commensurate with the function and experience, life insurance, health insurance, and an annual performance bonus.The ideal candidate will possess a Master's degree in...
-
Energy Transition Specialist
Há 2 dias
Lisboa, Lisboa, Portugal Phiture Tempo inteiroCompany OverviewE-REDES is a global energy company present in around 29 markets, with a focus on renewable energies. With over 45 years of experience, we have established ourselves as a leader in the energy transition. Our commitment to becoming all-green by 2030 drives our efforts to innovate and adapt to changing regulatory landscapes.SalaryThe estimated...
-
Regulatory Affairs Specialist
Há 1 mês
Lisboa, Lisboa, Portugal Icon Plc Tempo inteiroEmbark on a challenging career opportunity as a Regulatory Affairs Specialist at Icon Plc, a leading healthcare intelligence and clinical research organization.We are seeking an experienced individual to lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency...