Regulatory Affairs Associate - Hoeilaart, België - Viatris

Viatris
Viatris
Geverifieerd bedrijf
Hoeilaart, België

1 maand geleden

Sophie Dubois

Geplaatst door:

Sophie Dubois

beBee Recruiter
Beschrijving
7080 Mylan EPD BVBA

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 Associate will make an impact:

Key Responsibilities for This Role Include:

  • Preparation, submission and follow-up registrations (NP, MRP, DCP), and maintenance of registration dossiers (variations, renewals, PSURS) for which you are responsible.
  • Working in close collaboration with other departments of the local (QA/PV/Medical Affairs) and European Central RA Organization to collect information necessary for submissions.
  • Providing administrative support for pricing and reimbursement procedures and dossiers.
  • Actively participating in regulatory projects and interact with the other departments in the organization, affiliated companies, and headquarters.
  • Participating in the creation and maintenance of RA procedures and guidelines
  • Assuring good collaboration with QA and PV to ensure compliance of marketed products
  • Ensuring adherence to all regulatory requirements

The minimum qualifications for this role are:

  • Bachelor or Master Degree in Health Sciences or proven experience in the pharmaceutical industry
  • 2 to 5 years of relevant experience in Regulatory Affairs with a strong understanding of national and international regulatory requirements and guidelines for pharmaceutical products.
  • Experience working in an international pharmaceutical environment
  • IT skills: NeeS & eCTD, CESP submissions, Microsoft Office (Word, Excel, PowerPoint, Access)
  • Excellent trilingual abilities (NL, FR, EN) in reading, writing, and speaking. Knowledge of German is considered an asset.


Competencies- Excellent organization and project management skills- Capable to adapt in a fast-moving environment and able to deal with tight deadlines- Excellent interpersonal skills to assist in liaison with other departments within/outside the group in order to support regulatory requirements- Able to work pro-actively- Be able to work autonomously- Sense of responsibility and accuracy.


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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