- Responsible for the registration and life cycle management of assigned product portfolio: you will ensure that variations are submitted in a timely manner to keep dossiers in line with foreseen changes in manufacturing and marketing, to secure the continuity of supply.
- Maintain contacts with the Dutch Health Authority (CBG-MEB) over planned and pending submissions.
- Keep dossiers up-to-date and maintain version-controlled dossiers and product information in the Viatris document management systems conform to the Global SOPs.
- Ensuring and maintain regulatory compliance in line with various EU and international legislation
- In cooperation with the Artwork department responsible for artwork updates of the product labelling you are responsible for, within specified timelines, and for the regulatory approval of the final print proofs.
- Timely submission of the national phase for launches, and in case of CP timely availability of national text translations in EMA format, keeping track on the status of all RA steps needed for launch, and proactive communication with different stakeholders involved in the launch process.
- Provide local data for PSUR compilation for products you are responsible for. Submission of local additional Risk Minimization Measures.
- Support the medical department in the answering of consumer questions on products in your portfolio
- Life-science or pharmaceutical qualification, preferably as pharmacist or bachelor's degree with working experience in the pharmaceutical industry
- Minimum of 3 years of previous experience in a similar role/environment is preferred.
- Knowledge and understanding of the EU pharmaceutical legislation for medicinal products for human use, Notice to Applicants, local law on medicinal products, EU and local GMP/GDP legislation and associated guidance and other applicable regulations
- Good knowledge of Microsoft office and preferably with change and document management systems such as TrackWise and D2.
- Demonstrated ability to take initiatives, strategic thinking
- Ability to prioritize and keep an overview with complex situations/process and point out possible bottlenecks and consequences, is creative in finding solutions and achieving win-win situations
- Working language proficiency in both Dutch and English
- Demonstrated ability to take initiatives, strategic thinking and making well-considered decisions
- Ability to prioritize and keep an overview with complex situations/process and points out possible bottlenecks and consequences, is creative in finding solutions and achieving win-win situations
- Excellent communication skills, written and oral in both NL and EN
- Flexible, structured, and organised with an eye for detail
- Good knowledge of Microsoft office and preferably with change and document management systems such as TrackWise and D2.
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Regulatory Affairs Officer - Amstelveen, Nederland - Viatris
Beschrijving
Mylan B.V. 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:
Qualifications:
Skills and Competences:
At Viatris, we offer competitive salaries, benefits, flexible working 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.
At Viatris, we offercompetitivesalaries, benefitsandan 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.
