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
- 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.