Senior Regulatory Affairs and Compliance Specialist, Spain

hace 15 horas


Madrid, Madrid, España Beigene, Inc. A tiempo completo

Job Summary

We are seeking an experienced Senior Regulatory Affairs and Compliance Specialist to support our operations in Spain. The successful candidate will be responsible for providing local regulatory expertise and ensuring compliance with EU and local regulations.

About the Role

As a key member of our Regulatory Affairs team, you will contribute to the development and implementation of local regulatory strategies, provide technical support on regulatory matters, and collaborate with internal stakeholders to ensure alignment with company policies and procedures.

Key Responsibilities:

  • Provide local regulatory support and guidance to cross-functional teams, including Market Access, Medical Affairs, and Commercial Operations;
  • Develop and maintain relationships with local authorities, such as the Spanish Medicine Agency and Infarmed, to stay up-to-date on regulatory developments and ensure compliance;
  • Review and approve promotional and non-promotional materials, including SmPCs, labels, and package leaflets, to ensure accuracy and compliance with regulatory requirements;
  • Contribute to the preparation and submission of local regulatory agency applications and reports, and respond to regulatory authority queries;
  • Collaborate with local Quality Assurance teams to build and maintain a quality management system that meets local regulations;
  • Support the development of standard operating procedures and working practices, and ensure compliance with local codes and company rules;
  • Participate in local industry working group meetings and contribute to the development of processes and procedures needed;
  • Train new starters on local regulations and company policies.

Requirements:

To be considered for this role, you should have:

  • A degree in a relevant field, such as life sciences, law, or pharmaceutical sciences;
  • At least 5 years of experience in regulatory affairs, with a focus on EU and local regulations;
  • Proven expertise in regulatory affairs, including knowledge of EU legislation and local regulations;
  • Excellent communication and interpersonal skills, with the ability to build relationships with internal stakeholders and external partners;
  • Strong analytical and problem-solving skills, with the ability to interpret complex regulations and develop practical solutions;
  • Fluent English language skills, with proficiency in Spanish desirable.

What We Offer:

We offer a competitive salary and benefits package, including:

  • An estimated salary range of €60,000 - €80,000 per annum, depending on experience;
  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off;
  • Opportunities for professional growth and development, including training and mentorship programs;
  • A dynamic and supportive work environment, with a focus on teamwork and collaboration.

How to Apply:

If you are a motivated and experienced professional looking for a challenging role in regulatory affairs, please submit your application, including your resume and cover letter, through our online portal.



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