Senior Manager Regulatory Affairs

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Date: 10-May-2022

Location: Madrid, Spain, 28223

Company: Daiichi Sankyo Europe

 

Passion for Innovation. Compassion for Patients.

 


Daiichi Sankyo y sus 16.000 empleados en más de 20 países se dedican a la creación y suministro de productos farmacéuticos innovadores. En Europa, nos centramos en dos áreas: Cardiovascular, con una sólida cartera de medicamentos, que refleja nuestro compromiso y demuestra que cuidamos de cada latido del corazón; Oncología, cuyo objetivo es ser una compañía farmacéutica innovadora en 2025, proporcionando nuevas terapias a pacientes de todo el mundo. Nuestra sede europea está en Munich, Alemania, y tenemos filiales en 13 países europeos.

To provide regulatory guidance and support and execute regulatory activities in Spain for assigned marketed products and development projects:

 

Accountabilities / Measures:

 

•    Act as the regulatory liaison and contact person for AEMPS on regulatory matters, support or lead negotiations on regulatory issues and organize meetings and teleconferences, if required. Be the contact person with Health Authorities in the evaluation of medicinal products under a regulatory point of view.
•    Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives with particular focus on Spanish national regulations. Communicate important changes and trends within Regulatory Affairs and Spanish affiliate business functions when relevant. Design and revise SOPs and SOIs if required.
•    Where applicable, mentor/instruct and provide guidance to internal and external reports including consultants and service providers. Plan, assign and direct work; manage competing priorities as appropriate.
•    Where required, working with the European Regulatory Team provide regulatory advice on matters related to interventional and non-interventional clinical trials in Spain. 
•    Support to Market access functions in the preparation of documents and dossiers with regards regulatory information, for national Pricing and Reimbursement /Market Access submissions and discussions with the Ministry of Health.
•    In close collaboration with the European Regulatory Team develop regulatory strategies and advice and provide clear guidance and information to internal and external stakeholders in Daiichi Sankyo Spain.
•    Advise on national submission matters and any specific additional national requirements, identify deficiencies requiring resolution.
•    Provide and prepare national information and documents for submission including documents
required for labelling and request artwork implementations. (i.e: national code application, management of proofs of payment applications, national letters when applicable, and any other requirements).
•    Maintain licences of approved products, initiate and supervise implementation of changes; provide oversight and ensure regulatory compliance. Check the registration dossiers and their adaptation to the national requirements. Keep the EU headquarter informed about the status of submissions and implementation of changes
•    Provide pre-launch support and advise on Regulatory local needs to the Brand teams of the medicinal products (specific local regulations) aligned with Business needs and focusing on facilitate the access to patient.
•    Provide launch support and advise on regulatory questions of medicinal products to patients. (i.e.: SmPC, NPP, request of medical samples when applicable).
•    Represent Regulatory Affairs in internal and external interactions on regulatory topics and liaise with functional groups at the Spanish Affiliate, multidisciplinary project and working teams, license partners, authorities, and industry associations related to regulatory matters. Build up strong relationship with internal and external stakeholders at the Spanish affiliate and EU head office on regulatory matters.
•    Represent the Company in any Committee or group linked to the position (eg., Farmaindustria Regulatory Group). Manage regulatory activities with the Regulatory Departments of DAIICHI SANKYO EUROPE and partner companies.
•    Maintain constant contact with Quality functions and Technical Director in the Spanish affiliate and DSE.
•    Lead or support projects to enhance the functionality and improve processes of the organization and/or to adapt to a regulatory environment.

 

Technical/Professional Knowledge:

Essential 

•    Degree in Pharmacy, Medicine, Life or Natural Sciences.
•    Deep knowledge of European and Spanish national laws, regulations, guidelines and other requirements for human medicinal product marketing authorization and maintenance is essential.
•    +5 yrs Working experience in pharmaceutical industry, in Clinical Research Organizations or at a regulatory authority with proven experience in regulatory affairs with an emphasis on regulatory pre-submission and post-approval activities and preparation of new marketing authorization in Spain and Europe. 
•    Working experience with the AEMPS
•    Excellent interpersonal skills. Ability to communicate and work across functions effectively in a multinational organization to accomplish results.
•    Be detailed-oriented, well organized and self-motivated. Proven ability to plan, coordinate and lead activities simultaneously on multiple projects.
•    Very high ethical standards.
•    Understanding of development and life-cycle management of drugs and regulatory processes. Ability to interact and communicate effectively with regulatory authorities and stakeholders.
•    Computer proficiency (e. g. MS office, document management systems, databases), native level Spanish and excellent written and verbal communication skills in English


Desirable
•    PhD, post-doctorate or professional experience in pre-clinical research or clinical development, a TOPRA diploma or Master Degree in Regulatory Affairs or other relevant specialization.
•    Experience in Oncology and with centrally approved products
 

Trabajar en Daiichi Sankyo:


En Daiichi Sankyo, ofrecemos un lugar de trabajo donde serás escuchado. Todo lo que hacemos, lo hacemos con un alto nivel de compromiso y un claro enfoque en las necesidades de los pacientes. Sabemos que nuestra ambición por mejorar la vida de nuestros pacientes sólo puede lograse a través del poder de la colaboración y la exploración de nuevos enfoques. Por lo tanto, animamos a nuestros compañeros de toda Europa a ser valientes, a poner sus ideas sobre la mesa y a aprovechar las oportunidades para crecer. Cuando te unas a nuestra familia europea, formarás parte de una compañía dinámica donde todos, sin importar su función, se implican para conseguir obtener resultados.