senior Regulatory Affairs Officer Amsterdam
Deze vacature staat offline!
Farmaceutisch bedrijf in Amsterdam.
- 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 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.
- Bilingual NL/EN.
- Min 3 years experience in a similar role/environment is highly recommended
- A thorough 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 is highly recommended.
- 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.
Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:
Dr. Arjan van den Wijngaard|
Goeman Borgesiuslaan 77
3515 ET Utrecht
tel 030 231 7350
mobiel 06 50650550