Empleos actuales relacionados con Regulatory Affairs Manager - Madrid, Madrid - Intelstack

  • Legal Affairs Manager

    hace 2 semanas

    Madrid, Madrid, España Ford Motor A tiempo completo

    DescriptionFCE Bank plc is seeking an experienced, Spain-qualified lawyer to join its Legal Affairs team supporting the Madrid branch. This is a strategic role within a dynamic, international automotive finance environment, offering the opportunity to shape legal operations and ensure regulatory compliance across retail, leasing, and dealer financing...

  • Business Development Manager – Europe

    hace 2 semanas

    Madrid, Madrid, España Pillar Biosciences A tiempo completo

    Location: Western Europe (remote/hybrid; preferably near a major biotech/diagnostic hub). Territory: EU + associated European markets. Reports to: Head of EMEA Commercial and WW distributors.   About Pillar Biosciences Pillar Biosciences is a global leader in molecular diagnostics and next-generation sequencing (NGS) solutions. Our oncology portfolio...

  • Senior Manager Finance

    hace 4 días

    Madrid, Madrid, España Sonova International A tiempo completo

    Senior Manager, Finance – Alicante, SpainThe Senior Manager, Finance directs the financial affairs of the organization and acts as a business partner for senior leadership, providing strategic insights and decision support through performance controlling, management reporting, and analysis. This role ensures compliance with accounting standards, drives...

  • Manager, Clinical Monitoring

    hace 2 semanas

    Madrid, Madrid, España Rho A tiempo completo

    Join us in redefining what it means to work for a CRO. When you work at Rho, it's more than just a job—you become part of the Rho Factor. We're a proud bunch of science nerds who love tackling big challenges together. We're not your typical CRO, and we're not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at...

  • Business Development Manager

    hace 2 semanas

    Madrid, Madrid, España Aerones A tiempo completo

    We are seeking a senior commercial leader to drive Aerones' growth and market presence in Spain. This hybrid role combines business development with country management responsibilities. The successful candidate will be responsible for building a significant revenue base and long-term pipeline with major wind farm operators, OEMs, and service providers in...

  • Global Medical Lead

    hace 1 semana

    Madrid, Madrid, España Norgine A tiempo completo

    Want a 3D Career? Join Norgine.At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community. We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits. Bring everything about yourself that you're proud of, whether that's...

  • Operational Risk Advisory Manager

    hace 2 semanas

    Madrid, Madrid, España American Express A tiempo completo

    We back you with benefits that support your holistic well-being so you can be and deliver your best. This means caring for you and your loved ones' physical, financial, and mental health, as well as providing the flexibility you need to thrive personally and professionally:Competitive base salaries Bonus incentives Support for financial-well-being and...

  • Operational Risk Advisory Manager

    hace 2 semanas

    Madrid, Madrid, España American Express A tiempo completo

    At American Express, our culture is built on a 175-year history of innovation, shared values and Leadership Behaviors, and an unwavering commitment to back our customers, communities, and colleagues. As part of Team Amex, you'll experience this powerful backing with comprehensive support for your holistic well-being and many opportunities to learn new...

  • Business Development Manager

    hace 1 semana

    Madrid, Madrid, España Destinus A tiempo completo

    Imagine this – you're standing at the very intersection where strategy meets innovation. On one side, our engineers are developing cutting-edge UAV systems; on the other, our business development team is forging strategic partnerships that will define the future of defense. As a Business Development Manager focused on the Spanish defense sector, you will...

  • Urology, Regional Business Development Manager

    hace 5 días

    Madrid, Madrid, España Curium Pharma A tiempo completo

    Acerca de CuriumCurium es la mayor compañía de medicina nuclear del mundo con más de un siglo de experiencia en la industria. Desarrollamos, fabricamos y distribuimos productos radiofarmacéuticos de primera calidad para ayudar a los pacientes de todo el mundo. Nuestra probada herencia, combinada con un enfoque pionero, es el sello distintivo para ofrecer...

Regulatory Affairs Manager

hace 1 hora

Madrid, Madrid, España Intelstack A tiempo completo

Job Title: Contractor Local Regulatory Affairs Manager

Location:
Spain

Job Type:
Contract Role

Duration
: 11 Months

Job Description

We are inviting applications for the role of Contractor Local Regulatory Affairs Manager for the Turkey market. The ideal candidate will have extensive experience in regulatory affairs, specifically in lifecycle management (LCM) and line extensions for cardiovascular products. A strong understanding of ICH guidelines and local regulatory requirements in Turkey is essential.

Responsibilities

  1. Document Management
    : Author and review documents related to post-approval changes and line extensions, ensuring compliance with regulatory standards.
  2. Change Handling
    : Manage post-approval changes by assigning appropriate categories based on regulatory guidelines, ensuring all changes are documented and compliant.
  3. Issue Resolution
    : Escalate, notify, and resolve any issues that may impact final submissions to regulatory authorities.
  4. Lifecycle Management
    : Take end-to-end responsibility for the lifecycle management of products registered in the Turkish market, ensuring all regulatory requirements are met throughout the product's life.
  5. Internal Tracking
    : Maintain an internal tracker for post-approval changes and line extension submissions, ensuring timely updates as per anniversary requirements.
  6. Regulatory Strategy Development
    : Design regulatory strategies and make decisions regarding Chemistry, Manufacturing, and Controls (CMC) filings to support product registration and compliance.

Qualifications We Seek

Minimum Qualifications / Skills

  • Bachelor's Degree in Pharmacy (B. Pharmacy) or Master's Degree in Pharmacy (M. Pharmacy).

Preferred Qualifications / Skills

  • Ensure adherence to specific project specifications or standards throughout the submission lifecycle.
  • Demonstrate effective time management and organizational skills to manage multiple time-sensitive assignments.
  • Understand the business value of quality and compliance, adjusting behaviors to drive high-quality deliverables.
  • Solve problems independently, utilizing existing solutions from a new perspective.
  • Communicate complex issues effectively both verbally and in writing to build alignment among stakeholders.
  • Adapt to changing environments while staying current with new processes and procedures.
  • Depending on experience level, mentor newly hired staff or lead a team of junior staff.
  • Flexibility in responding to changing priorities or unexpected events while balancing multiple tasks to achieve business goals.
  • Need to know Spanish language and Spain regulations