Manager Regulatory Affairs, Drug Safety

vor 1 Woche

Brunn am Gebirge, Österreich Grünenthal Vollzeit

**Country**:Austria**City**:Brunn am Gebirge**Department**:Research & Development**Job ID**:43478- If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In
- **Research & Development**, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.**What the job looks like**:

- Ensure local regulatory approval and maintenance of product licenses.- Ensure maintenance of product information texts and the review of regulatory aspects of company product related materials.
- Maintain overview of the registration status for all products in Austria, including tracking of all submissions and commitments.
- Operational support to Drug Safety DACH Team in e.g. ICSR identification, Regulatory Intelligence monitoring, implementing risk minimization measures
- Maintain and monitor compliance infrastructure within the company to ensure compliance with local pharmaceutical industry practices, Pharmig Code and GRT Code of Conduct.
- Plan and conduct compliance trainings.
- Active participation in compliance audits and inspections.**What you'll bring to the table**
- o University degree in economics or sciences and/or advanced degree in health or life sciences.
- Work experience in regulatory affairs and drug safety within the pharmaceutical industry.
- Thorough knowledge of regulatory and drug safety processes and relevant Regulations (EU legislations and guidelines, local law etc).
- Preferably knowledge in NeeS/eCTD publishing software (e.g.DocuBridge).
- Very structured and attention-to-detail working style.
- Strong communication, negotiation and problem solving skills.
- Ability to work flexible, proactive, open, adaptable to environment and supportive of training.
- Strategic thinking, commercial awareness and ability to work in a global matrix environment.
- Fluent business English language skills.

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