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Regulatory Affairs Officer

Regulatory Affairs Officer

ASPHALIONsalamanca, España
Hace 9 días
Descripción del trabajo

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Asphalion is growing, and we are looking for a Regulatory Affairs Officer with experience in the pharmaceutical industry. We seek someone who loves new challenges, enjoys working in an international environment, and wants to grow with us!

Main responsibilities :

  • Submission of MAA, variations, renewals, and procedures worldwide, including EU, US, CH, and RoW.
  • Pricing and Reimbursement.
  • Requesting information from Health Authorities.
  • Adapting documentation to the Transparency Policy 0070.
  • Reviewing promotional materials, packaging, and labelling.
  • Leading and managing regulatory projects to ensure timely and successful execution.

Requirements :

  • At least 2 years of experience in Regulatory Affairs within Pharma departments.
  • Fluent in English (C1) and Spanish.
  • Academic degree in Life Sciences.
  • Advanced IT skills, especially MS Office.
  • Proactive, good communication skills, accurate, and detail-oriented.
  • Why work at Asphalion?

  • Home office, hybrid, or remote work model (located anywhere in Spain).
  • Variety of projects, new challenges, and experiences.
  • Training and personal development programs.
  • A professional, inclusive, and high-performance environment to develop your skills and grow your career.
  • Company culture centered on Passion, Flexibility, Commitment, Quality, and Camaraderie.
  • Multinational team with over 15 nationalities.
  • Well-being programs supporting physical, psychological, and emotional health.
  • Seniority level : Associate
  • Employment type : Full-time
  • Job function : Management
  • Industry : Pharmaceutical Manufacturing
  • This job posting is active. Referrals can double your chances of an interview at ASPHALION. Get notified about new Regulatory Affairs Officer roles in Spain .

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    Regulatory Officer • salamanca, España