At
Por favor, lea detenidamente la siguiente descripción del puesto para asegurarse de que encaja con el perfil antes de enviar su solicitud.
Auren Personas
we work from the Recruitment & Executive Search division and we are dedicated to providing specialized Human Resources consulting services.
We are currently collaborating with a leading Pharmacy industry company based in Madrid, which is looking to add a Regulatory Affairs and Local QPPV to its team.
About the role:
Supervise and coordinate the execution of formulation, manufacture, dossier construction, registration of products. Also supervise the registration of companies, where applicable. Act as the local QPPV
Duties required:
Assist on products registration (human medicines, medical devices, cosmetics, food supplements, etc), variations, renewals, or any other activity regarding the maintenance of the dossiers (e.g., readability tests). These procedures could be National or European procedures (Centralized, Decentralized and Mutual Recognition Procedures).
Ensure regulations compliance (on both European and local regulations) for all Cipla products.
eCTD compilation
Collect and evaluate scientific data.
Prepare labelling, PIL, SmPC and mockups of medicinal products, and adaptation to current QRDs.
Provide strategic advice throughout the development of new products.
Managing teams of colleagues involved with the development of new dossiers.
Keeping abreast of international legislation, guidelines, and customer practices in all countries that the company is working.
Advise clients and manufacturers on regulatory requirements.
Work with specialist computer software and resources (eCTDmanager, Lorenz Validator, RAEFAR, etc).
Negotiate with regulatory authorities for marketing authorisation, variations, or any other required activity for the approval of client’s medicinal products in Spain and other countries, as needed.
Submit price & reimbursements procedures for the new products including negotiations with the MOH
Support the quality team in the local release of the products
Act as the point of contact for the Pharmacovigilance department, being the local QPPV
Requirements :
At least 3 years in a similar work position.
B. sc degree in life science (Chemistry, Biology, Pharmacy, etc).
Master or related course in Regulatory Affairs will be desirable.
English level: High (spoken and written).
Benefits:
Professional development opportunities in an international environment
Partial remote work options.
We appreciate your application and interest, we look forward to meeting your talent!
At Auren Selección & Executive Search, we offer a global range of solutions for the identification, recruitment, selection and evaluation of talent.
We provide local and international services for any volume. xkdbapo We have highly specialized teams, more than 20 years of experience and proven success stories.