Regulatory Affairs Senior Specialist

FARMAPROJECTS SAU; Madrid; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

Una empresa innovadora busca un Especialista Senior en Asuntos Regulatorios para unirse a su equipo en Madrid. En esta emocionante posición, serás responsable de desarrollar estrategias regulatorias y gestionar solicitudes de autorización de comercialización. Con un enfoque en la mejora continua y un entorno multicultural, tendrás la oportunidad de contribuir a la transformación del negocio mientras disfrutas de beneficios corporativos como seguro de salud y oportunidades de aprendizaje. Si tienes una sólida experiencia en la industria farmacéutica y estás listo para un nuevo desafío, ¡esta es la oportunidad perfecta para ti!

Servicios

Ticket Restaurant

Health Insurance

Annual learning & development

Mental healthcare support

Team-driven celebrations and events

Formación

• 8+ years of experience in Regulatory Affairs and the Pharmaceutical Industry.
• Strong understanding of EMA, ICH, and RoW regulations.

Responsabilidades

• Develop regulatory strategies and manage Marketing Authorisation applications.
• Ensure compliance with regulatory processes and maintain accurate documentation.

Conocimientos

Regulatory Affairs

Pharmaceutical Industry Knowledge

eCTD Submission

Project Coordination

Communication Skills

Life Sciences Degree

Regulatory Processes Knowledge

High Learning Agility

Educación

Bachelor's or Master's degree in Life Sciences

Herramientas

Regulatory Database

Descripción del empleo

Farmaprojects, 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 Regulatory Affairs Senior Specialist to join our Regulatory Affairs Department and ready to start from January 2025!

What We Offer:

1. To be part of the transformation of the business
2. Continuous learning opportunities
3. A rapidly expanding company
4. A multicultural environment open to new ideas
5. A company culture that is a reflection of shared values
6. Be part of the regulatory strategies

You will be part of an exciting team contributing to the business whilst enjoying the following corporate benefits:

• Ticket Restaurant
• Health Insurance
• Annual learning & development
• Mental healthcare support and services
• Team-driven celebrations and events
• and more!

Requirements:

Specific Activities:

1. Be responsible for the development of assessments and strategic regulatory plans for strategic product planning.
2. Take part in the definition of Commercial Strategy since project approval until dossier submission - Target Clients / N licenses / Business Model / Go to market strategy etc.
3. Definition of Regulatory Strategy since project approval until dossier submission - Proactive MA strategy and Maintenance Plan.
4. Take part in the definition of D1 Launch Strategy - FTO, API etc.
5. Establish a strategic plan for priority products to maximize their performance and life cycle; by taking part in high-level LCM strategy.
6. Support the development of initial or alternative regulatory strategies.
7. Manage new Marketing Authorisation applications (slot request, dossier preparation – Module 1 – and submission, procedure follow-up with Health Authorities including responses submission and product information management in local languages) in EU.
8. Manage variations (preparation of variations, shipment to Health Authorities (in EU), shipment to the customer & preparation of necessary responses) in EU and non-EU.
9. Manage renewals (preparation of Module 1 & 2, compilation and submission of the renewal documentation for Farmaproject’s MAs, shipment of renewal documentation to the customer & preparation of necessary responses) in EU.
10. Manage other post-approval activities: Sunset clause exemption requests, withdrawal requests & post-approval commitments.
11. Create eCTD sequences for new submissions and any post-approval activity of the lifecycle management of the product.
12. Maintain accurate and up-to-date Regulatory information on all procedures in the corresponding Regulatory database implemented in the Quality Management System of the company.
13. Continuous developmental upgrade of knowledge with regards to the regulatory legislation in countries where Farmaprojects has clients and/or Marketing Authorisations and provide information to others when needed.
14. Follow up on clients and regulatory procedures all around the world.
15. Manage any other legal/administrative documentation required such as CPPs, price reimbursement, new applications/variations/annual fees, marketing communications with the corresponding authorities etc.

Skills:

• Bachelor's or Master's degree in Life Sciences
• 8-year work experience in Regulatory Affairs Department and Pharmaceutical Industry.
• Relevant experience in Regulatory Affairs
• Solid understanding of the pharmaceutical industry (Europe, Canada, Int. Markets)
• Good knowledge of EMA, ICH and RoW regulations, guidelines, and regulatory processes regarding drug development, approval, and maintenance of marketing authorisations.
• Familiarity with eCTD submission, compilation, and publishing using specific tools.
• Good commercial and product awareness.
• Sound administrative and systems background.
• High proactivity and coordination skills.
• High learning agility and open mindset for change.
• Ability to develop good cross-functional working relationships and tactical coordination of projects.