Manager Global Regulatory Affairs
hace 11 días
Barcelona
About ANA B ION La siguiente información ofrece un resumen de las habilidades, cualidades y cualificaciones necesarias para este puesto. We are ANA B ION , an international biotech company dedicated to helping people live longer and healthier lives. Our strong portfolio spans effective, safe, and affordable solutions in Life Sciences, including innovative treatments, biosimilars, and gene therapies for oncology, autoimmune disorders, and rare diseases such as SMA and hemophilia. About the Role We are seeking a Global Regulatory Affairs Manager who will play a pivotal role in advancing our international portfolio (spanning high‑technology biological products) across markets in Asia, Africa, the Middle East, Latin America, and Europe. In this role, you will lead and coordinate global regulatory activities, from strategy development to the preparation and submission of dossiers for multiple regions. You will work closely with regulatory authorities, partners, and cross‑functional teams, ensuring timely approvals, efficient life‑cycle management, and full compliance with diverse international requirements. This position is ideal for an experienced regulatory leader who thrives in a dynamic, multicultural environment and is ready to take ownership of complex global processes while guiding and empowering a distributed regulatory team. Responsibilities: • Manage a team of at least 10 RAMs across various international regions (Asia, Africa, the Middle East, Latin America) to ensure the execution of international product registration processes for ANA B ION's portfolio in foreign markets., • Oversee the preparation and submission of registration dossiers in foreign countries across Asia, Africa, the Middle East, Latin America, and Europe. This includes initial registrations, dossier updates, registration renewals, pharmaceutical expertise submissions, and responses to additional inquiries from regulatory authorities and partners. Work includes handling registration dossiers for high‑technology biological medicinal products., • Develop regulatory strategies for the department’s registration projects in accordance with legislative and internal timelines, and maintain valid marketing authorizations for medicinal products in Asia, Africa, the Middle East, Latin America, and Europe., • Interact with regulatory authorities in Asia, Africa, the Middle East, Latin America, and Europe, as well as with partners and contractors within the framework of contractual registration activities., • Develop the department’s budget and monitor its execution., • Oversee the accuracy and completeness of information related to all departmental registration processes within the company’s internal systems., • Higher education in Law or Pharmacy., • 5+ years of experience in a senior regulatory leadership role with full responsibility for international registration processes., • Proven expertise in building, managing, and optimizing regulatory workflows across multiple international markets., • Strong understanding of international regulatory frameworks and requirements for the registration and development of biological products., • Hands‑on experience with preparation, submission, and maintenance of registration dossiers, including initial registrations, variations, renewals, and responses to authority inquiries., • Experience working with biological / high‑technology medicinal products and corresponding regulatory dossiers., • Ability to oversee regulatory strategy development, ensuring compliance with legislative timelines and diverse regional regulations., • Strong leadership and people‑management skills, including experience overseeing teams of regulatory professionals across multiple countries., • Excellent cross‑cultural communication and the ability to collaborate effectively with stakeholders in varied geographic and regulatory environments., • High degree of organizational and project‑management skills, capable of coordinating multiple parallel submissions and timelines., • Strategic mindset with the ability to make informed decisions, anticipate regulatory risks, and proactively adjust strategies., • Strong attention to detail combined with the ability to navigate complex regulatory documentation and requirements., • Ability to manage external interactions confidently, including regulatory authorities, partners, and contractors., • Problem‑solving orientation and resilience in navigating evolving regulatory environments., • Access to global expertise, international cross‑functional collaboration, and long‑term career development within ANA B ION ., • A results‑driven environment where strong performance is recognized and rewarded., • The opportunity to play a meaningful role in building an ambitious, fast‑growing global biotechnology company. xcskxlj, • A competitive compensation package with performance‑based bonuses.
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