Regulatory Affairs Officer
2 semanas atrás
1422 Mylan, Lda.
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership - Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here’s how the Regulatory Affairs Officer role will make an impact:
Key responsibilities for this role include:
- Management of regulatory affairs activities in the Portuguese affiliate, in line with the company´s policies, procedures and practices, and all legal requirements with a close liaison with regional office and local manager
- Ensure regulatory activities related to the lifecycle management of allocated processes: renewals, type I and II and AIM transfers
- Responsible for regulatory activities related to marketing authorization (NPs, DCPs, MRPs) in conjunction with regional teams, whenever applicable
- Translation, submission, and monitoring of national phases
- Payment of fees
The minimum qualifications for this role are:
- Master´s Degree in Pharmacy or equivalent and at least 3 years of pharmaceutical experience is required
- Written and oral communication skills
- IT skills, particularly in relation to using databases/IT platforms
- Ability to work under pressure and to strict deadlines
- Team-working
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.
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