Senior Regulatory Affairs Director
hace 1 semana
This is what you will do:
The Senior Regulatory Affairs Director (RAD), Global Regulatory Strategy will be responsible for overseeing the development and implementation of global regulatory strategies for all assigned products and therapeutic areas, with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.
This individual will, with a high sense of urgency, lead cross-Regulatory teams and be accountable to provide key regulatory input to Global Program and/or Medicine Teams (GPTs/GMTs) deliverables. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
You will be responsible for:
Provide regulatory strategic oversight for products and/or projects in the relevant therapeutic areas/portfolio, as assigned, aligned to overall Enterprise objectives through initial registration and subsequent lifecycle management. Lead and support staff in preparation for regulatory authority meetings and provide input to submission strategy and other critical regulatory documents. May represent Alexion as point contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders. Provide input to internal Governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise. Actively collaborate with Senior Management and Enterprise functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide portfolio or therapeutic level regulatory insight and broader drug development expertise. Actively be up to date on latest regulatory requirements and trends, and contribute to the shaping of the regulatory science environment. Support regulatory intelligence and policy priorities based on Alexion and AstraZeneca's internal knowledge and expertise. Can provide support as needed to Business Development activities of the Enterprise, notably supporting Regulatory due diligence, gap assessment and resource needs. Ensure exemplary behavior, leadership, ethics and transparency within the Enteprise, with Health Authorities and other external stakeholders.You will need to have:
Qualifications
10+ years of Regulatory experience in the pharmaceutical industry, with significant track record on Global Strategies. Strong knowledge of drug development and regulatory policy, coupled by excellent scientific and business judgment. Experience providing strategic regulatory advice for the global development of products in several major jurisdictions such as EU, US, China, Japan through all stages of development including pre-approval and marketed assets. Successful track record in registering and overseeing regulatory strategies for assets. Ability to manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion. Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization, especially Senior Management. Strong interpersonal, and written/verbal communication skills. Proven track record practicing sound judgment as it relates to risk assessment Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information.Education
Bachelor's Degree, life science highly desirable Postgraduate degrees relevant to the role (e.g. MSc, PhD) a plus Additional certification and/or training relevant to the role over the pastCompetences
Excellent use of Microsoft 365 (Office) tools, ideally well skilled on the use of PowerPoint Proficient in English in the Corporate setting. Additional languages are a plusDate Posted
05-Jun-2024Closing Date
13-Jun-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.
-
Senior Regulatory Affairs
hace 1 semana
Barcelona, Barcelona, España Antal International Network A tiempo completoDesde el departamento de Pharma de Antal International nos encontramos en búsqueda de un Senior Regulatory Affairs para trabajar en una importane multinacional Dermocosmética para la parte de regulación de medicamentos ubicada en Barcelona. Formación Universitaria en Ciencias de la SaludMás de 4 años con posiciones de Regulatory Affairs en Industria...
-
Senior Regulatory Affairs
hace 1 semana
Barcelona, Barcelona, España Antal International Network A tiempo completoDesde el departamento de Pharma de Antal International nos encontramos en búsqueda de un Senior Regulatory Affairs para trabajar en una importane multinacional Dermocosmética para la parte de regulación de medicamentos ubicada en BarcelonaRequisitos:Formación Universitaria en Ciencias de la SaludMás de 4 años con posiciones de Regulatory Affairs en...
-
Senior Regulatory Affairs
hace 1 semana
Barcelona, Barcelona, España Antal International Network A tiempo completoDesde el departamento de Pharma de Antal International nos encontramos en búsqueda de un Senior Regulatory Affairs para trabajar en una importane multinacional Dermocosmética para la parte de regulación de medicamentos ubicada en Barcelona.Requisitos:Formación Universitaria en Ciencias de la Salud Más de 4 años con posiciones de Regulatory Affairs en...
-
Senior Regulatory Affairs
hace 1 semana
Barcelona, Barcelona, España Antal International Network A tiempo completoDesde el departamento de Healthcare de Antal International nos encontramos en búsqueda de un Senior Regulatory Affairs para un importante Laboratorio Farmacéutico Veterinario que desarrolla, fabrica y comercializa productos farmacéuticos para animales en distintas líneas de negocio: ganadería, avicultura, apicultura y animales de compañía. Como Senior...
-
Senior Regulatory Affairs Director
hace 1 semana
Barcelona, Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completoLocation: Barcelona, SpainJob reference: R-201477Date posted: 06/05/2024This is what you will do:The Senior Regulatory Affairs Director (RAD), Global Regulatory Strategy will be responsible for overseeing the development and implementation of global regulatory strategies for all assigned products and therapeutic areas, with the intention of achieving...
-
Senior Regulatory Affairs
hace 1 semana
Barcelona, Barcelona, España Antal International Network A tiempo completoDesde el departamento de Healthcare de Antal International nos encontramos en búsqueda de un Senior Regulatory Affairs para un importante Laboratorio Farmacéutico Veterinario que desarrolla, fabrica y comercializa productos farmacéuticos para animales en distintas líneas de negocio: ganadería, avicultura, apicultura y animales de compañía.Como Senior...
-
Senior Director, Regulatory Affairs Excellence Eucan
hace 1 semana
Barcelona, Barcelona, España AstraZeneca A tiempo completoThis role coordinates and drives the Business Strategy for EUCAN Marketing Company Regulatory Affairs (EUCAN MCRA) including the digital agenda, simplification, and improvement projects in close collaboration with the Executive Director EUCAN, Senior Regional Director EU and EUCAN Marketing Company Regulatory Affairs (MCRA) Heads and all relevant Global...
-
Senior Regulatory Affairs Specialist
hace 1 semana
Barcelona, Barcelona, España Farmaprojects A tiempo completoFarmaprojects, part of Polpharma Group B.V., is a B2B Pharmaceutical Laboratory company offering a broad Portfolio of Generic Pharmaceutical Products and Value Added Medicines.For our office in Barcelona, Farmaprojects is looking for a new Senior Regulatory Affairs Specialist to join our Regulatory Affairs Department.At Farmaprojects, you can expect:To be...
-
Regulatory Affairs
hace 1 semana
Barcelona, Barcelona, España CREACIONES AROMATICAS INDUSTRIALES, S.A. A tiempo completoGrupo Carinsa, con más de 30 años de experiência en el sector de las fragancias y los aromas, busca perfil de Regulatory AffairsSe responsabilizará de elaborar la documentación técnica relativa a los productos fabricados por la empresa, por lo que deberá conocer la normativa vigente, relacionada con clasificación y envasado de productos químicos....
-
Regulatory Affairs Director
hace 1 semana
Barcelona, Barcelona, España Instituto Grifols SA A tiempo completoWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
-
Regulatory Affairs
hace 1 semana
Barcelona, Barcelona, España CREACIONES AROMATICAS INDUSTRIALES, S.A. A tiempo completoGrupo Carinsa, con más de 30 años de experiência en el sector de las fragancias y los aromas, busca perfil de Regulatory AffairsSe responsabilizará de elaborar la documentación técnica relativa a los productos fabricados por la empresa, por lo que deberá conocer la normativa vigente, relacionada con clasificación y envasado de productos químicos....
-
Eu Regulatory Affairs Director/senior Regulatory
hace 1 semana
Barcelona, Barcelona, España AstraZeneca A tiempo completoAre you a strategically focused Regulatory Affairs professional and would like to play a central role in crafting innovative drug development strategies and gaining fast, efficient regulatory approvals? If so, read on...At AstraZeneca, we work with a diverse set of minds, all united by a shared passion to learn, grow and discover.Who we areDriven by a sense...
-
Regulatory Affairs
hace 1 semana
Barcelona, Barcelona, España Creaciones Aromaticas Industriales, S.A. A tiempo completoGrupo Carinsa, con más de 30 años de experiência en el sector de las fragancias y los aromas, busca perfil de Regulatory AffairsSe responsabilizará de elaborar la documentación técnica relativa a los productos fabricados por la empresa, por lo que deberá conocer la normativa vigente, relacionada con clasificación y envasado de productos químicos....
-
Regulatory Affairs Director
hace 1 semana
Barcelona, Barcelona, España AstraZeneca A tiempo completoAre you a strategically focused Regulatory Affairs professional and would like to play an integral part in crafting drug development and gaining fast, efficient approvals? If so, read on...At AstraZeneca, we have a team united by a shared passion to learn, grow and discover.This role, as a Regulatory Affairs Director (RAD), provides strategic and operational...
-
Regulatory Affairs Director
hace 1 semana
Barcelona, Barcelona, España AstraZeneca A tiempo completoAre you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read onAt AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the...
-
Regulatory Affairs
hace 1 semana
Barcelona, Barcelona, España Creaciones Aromaticas Industriales, S.A. A tiempo completoGrupo Carinsa, con más de 30 años de experiência en el sector de las fragancias y los aromas, busca perfil de Regulatory AffairsSe responsabilizará de elaborar la documentación técnica relativa a los productos fabricados por la empresa, por lo que deberá conocer la normativa vigente, relacionada con clasificación y envasado de productos químicos....
-
Senior Regulatory Affairs Specialist
hace 1 semana
Barcelona, Barcelona, España FARMAPROJECTS SAU A tiempo completoFarmaprojects, part of Polpharma Group B.V., is a B2B Pharmaceutical Laboratory company offering a broad Portfolio of Generic Pharmaceutical Products and Value Added Medicines.For our office in Barcelona, Farmaprojects is looking for a Senior Regulatory Affairs Specialist to join our Regulatory Affairs Department.What to Expect at Farmaprojects:Contribution...
-
Regulatory Affairs Manager
hace 2 meses
Barcelona, Barcelona, España Robert Walters A tiempo completoRobert Walters is hiring a Regulatory Affairs Manager in Barcelona.Our client is an important pharmaceutical company specialized in medical nutrition.As a Regulatory Affairs Manager, the candidate reports to the Director of RD&A.Its objective is to ensure regulatory compliance of the product portfolio (marketed and investigational products) in all the...
-
Regulatory Affairs Manager
hace 1 semana
Barcelona, Barcelona, España Robert Walters A tiempo completoRobert Walters is hiring a Regulatory Affairs Manager in Barcelona.Our client is an important pharmaceutical company specialized in medical nutrition.As a Regulatory Affairs Manager, the candidate reports to the Director of RD&A.Its objective is to ensure regulatory compliance of the product portfolio (marketed and investigational products) in all the...
-
Senior Director, Regulatory Affairs Eu
hace 1 semana
Barcelona, Barcelona, España AstraZeneca A tiempo completoThis role is the key account manager for the regulatory EU Marketing Company (EUMC) thereby managing and coordinating all EU regulatory affairs CP-related matters in close collaboration with local EU Marketing Company Regulatory Affairs (MCRA) Heads, EU marketing company presidents and all relevant Global Functions.Internal Focus: Responsible for EUMC legal...
