Regulatory Affairs Manager

hace 6 días

Sant Cugat del Vallès Barcelona provincia, España Haema A tiempo completo

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Help to grow one of the world’s most innovative companies

We are looking for a Regulatory Affairs Manager who will be the responsible to ensure compliance of the priority plan, as well as coordination of compilation, submission and following up of product
registration and/or renewal and/or changes/variations dossiers, and any other regulatory documentation, within the company timelines. Determine and execute actions necessary for licenses and regulatory procedures are in compliance with domestic and international licensing requirements.

**What your responsabilities will be**
- Assess worldwide regulatory product registration strategy
- Review and, if needed, prepare and send the registration and/or renewal and/or changes/variations dossiers of the relevant products.
- Review and, if needed prepare and send official responses to any Health Authority questions.
- Represent the regulatory function in communication with affiliates, outside companies and Health Authorities.
- Review and assess regulatory impact for product or manufacturing changes.
- Manage/coordinate that licenses are adapted to current regulations.
- To coordinate/approve packaging material.
- To organize the work of the technicians under their responsibility and supervise the fulfillment of the annual
projects, when applicable
- To know the legislation applicable to different projects.
- To support general matters of the Regulatory Affairs Area.
- To coordinate SOPs preparation.

**Who you are**
- You have a Bachelor in Science Degree (Pharmacy, Chemistry ) or Engineer.
- You have at least 5 years of experience in this area.
- Your English is advance.
- Rigor and ability to work as part of the regulatory team and with cross functional teams to meet the objectives.
- Flexible and adaptable to changing situations/projects within the company/industry.
- Ability to work under tight timelines to meet deadlines and business objectives.
- Troubleshooting skills.
- Ability to clearly communicate verbally and in writing.
- Proactive and positive attitude.
- Strong analytical skills and ability to summarize and evaluate.
- Skills with the use of MS tools.

**What we offer**
- Permanent Contract.
- Full Time timetable.
- Attractive Benefits of being part of Grifols team.
- Location: San Cugat del Vallés (hybrid). Flexibility for U Plan.

Grifols is an equal opportunity employer.

**Location**:mfield6**:cust_building**

Learn more about Grifols

  • Biocides Regulatory Affairs Lead — Hybrid

    hace 2 semanas

    Sant Cugat del Vallès, España Perrigo Company plc A tiempo completo

    A leading healthcare company is seeking a Regulatory Affairs Manager to lead the regulatory strategy for biocidal products, manage a high-performing team, and ensure compliance across multiple markets. Ideal candidates will have a strong background in regulatory affairs with over 5 years of experience, particularly with biocidal products and dossier...

  • Category Regulatory Affairs Manager

    hace 7 días

    sant cugat del vallès, España Perrigo Company plc A tiempo completo

    Category Regulatory Affairs Manager Perrigo Company plc At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self‑Care market and the largest U.S. store brand provider of over‑the‑counter and infant formula. Dedicated...

  • Category Regulatory Affairs Manager

    hace 2 semanas

    Sant Cugat del Vallès, España Perrigo A tiempo completo

    Description Overview Perrigo is seeking a dynamic and experienced Regulatory Affairs Manager to lead regulatory strategy and execution for our biocidal product portfolio across multiple territories.  This role offers a unique opportunity to shape regulatory pathways, drive compliance excellence, and lead a high-performing team within a fast-paced,...

  • Regulatory Affairs Senior Food

    hace 6 días

    Sant Cugat del Vallès, Barcelona provincia, España Page Personnel España A tiempo completo

    Compile and draft technical dossiers - Perform data audits and gap analyses - Design studies to support dossiers - Draft protocols and review study reports - Liaise with external laboratories and suppliers - Monitor studies required for EU registration - Perform relevant statistical analyses of study data - Verify legal status of food and feed ingredients -...

  • Regulatory Affairs Technician — Compliance, Trials

    hace 2 semanas

    Sant Cugat del Vallès, España AB-BIOTICS A tiempo completo

    A leading pharmaceutical company in Sant Cugat del Vallès is seeking a qualified regulatory affairs specialist. Responsibilities include studying scientific documents, ensuring compliance with legal authorities, managing product trials, and negotiating with regulatory bodies.

  • Regulatory Affairs Specialist

    hace 3 días

    Sant Cugat del Vallès, España Grifols A tiempo completo

    Would 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...

  • NAT Regulatory Affairs Specialist

    hace 3 días

    Sant Cugat, España Grifols, S.A A tiempo completo

    A global healthcare company is seeking a Nucleic Acid Testing (NAT) Regulatory Affairs Specialist to join their Diagnostic Regulatory Affairs department. The candidate will prepare technical documentation, manage product registrations, and ensure compliance with regulations. Applicants should possess a Bachelor's in Health Sciences, experience in Regulatory...

  • Regulatory Affairs Manager

    hace 2 semanas

    Barcelona, España Hezuo Ltd A tiempo completo

    Regulatory Affairs Manager As Regulatory Affairs Manager , you’ll play a pivotal role in supporting the geographical expansion of a dietary supplement ingredient business . Based in Barcelona , you’ll coordinate regulatory activities that ensure timely and compliant product registrations, authorizations, marketing & scientific communication across...

  • Regulatory Affairs Technician — Compliance, Trials

    hace 2 semanas

    Sant Cugat del Vallès, España AB-BIOTICS A tiempo completo

    A leading pharmaceutical company in Sant Cugat del Vallès is seeking a qualified regulatory affairs specialist. Responsibilities include studying scientific documents, ensuring compliance with legal authorities, managing product trials, and negotiating with regulatory bodies. The ideal candidate should have experience in Pharma, OTC, and pharmaceutical...

  • Regulatory Affairs Manager

    hace 2 semanas

    Barcelona, España Jordan martorell s.l. A tiempo completo

    Job Title: European Regulatory Affairs Manager Location: Madrid, Spain - Hybrid Remuneration: Competitive salary and package Regulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a personable and...