Regulatory Affairs Officer

Regulatory Affairs Officer

Our team in Barcelona is growing!

Our team’s mission is our passion: to work together with our clients to generate ideas and implement solutions that contribute to better health in all our lives.

Do you want to be a part of this project and to be in contact with regulatory affairs departments and health authorities? This is your opportunity!

  1. Main responsibilities:
  • Submissions of NA, variations, renewals to different regions and procedures worldwide
  • CMC preparation of documentation: Module 3 and Module 2.3 and CMC Variations
  • Pricing and Reimbursement
  • Request to Health Authorities
  • Due Diligences
  • And overall management of Regulatory Activities (CP, MRP, DCP, national, variation)
  • Follow up of potential clients

According the project all activities can be done for medicinal products, medical devices, cosmetics, biocides, and other regulated products.

We offer you:

  • A highly professional, dynamic, ambitious & international working environment with flat hierarchies and short decision paths. More than 12 nationalities!
  • A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship
  • Training and personal development program.
  • An organization with highly professional people to develop with.
  • A position with challenging tasks.
  • Compensation and Social Benefits plan.
  • Work- life balance and flexible hours.
  • Enjoy intensive hours on Friday.
  • Home Office

Requirements

  • +2 years experience in Regulatory Affairs in Pharmacy Industry it’s required.
  • Background in Health Sciences.
  • Knowledge of Microsoft Office.
  • Good analytical, quality orientation and customer focus skills.
  • High level of English and Spanish
  • High willingness to learn and take on new challenges and responsibilities
  • A team player with good communication skills
  • The ability to handle multiple tasks in a fast paced environment
  • Truckloads of motivation, positivity and enthusiasm
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