Regulatory Affairs Officer

Regulatory Affairs CMC Job Offer

Regulatory Affairs Officer

We are looking for a Regulatory Affairs Officer!

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 be in contact with regulatory affairs departments?

This is your opportunity! Join us!

The Regulatory Affairs Officer main responsibilities are:

  • 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.

 

Desired Skills & Experience:

  • Scientific or engineering academic background
  • +2 years experience in Regulatory Affairs
  • Fluent English & Spanish
  • Proactive
  • Good in communication and negotiation skills
  • Organized and methodical

 

Why join us?

  • Working together and with our clients we generate ideas and implement solutions that contribute to improving health in all our lives.
  • Team composed of people of 12th different nationalities.
  • Opportunity to take part in a wide variety of regulatory affairs projects, that constantly will bring you new challenges and experiences .
  • Training plans and personal development trainings.
  • Compensation and benefits plan.
  • Reconciliation mesures and flexible hours.
  • Enjoy intensive hours on Friday.

 

Send us your CV today or apply here!

Regulatory Affairs CMC

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