Regulatory Affairs Officer
il y a 3 jours
**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**
**Regulatory Affairs Officer**
**YOUR TASKS AND RESPONSIBILITIES**
- For the assigned established product portfolio, deliver regulatory milestones for The Netherlands and/or Belgium by:
- compiling local regulatory submissions and supporting regional regulatory submissions,
- providing local translations of the product information,
- ensuring timely implementation of product information and packaging changes in production, and by
- translating and submitting educational materials.
- Responsible for regulatory compliance, database maintenance and archiving for the assigned product portfolio.
- Representation of Bayer as a competent and reliable partner to the local Health Authorities in assigned regulatory matters.
- Provide support with Clinical Trial Application preparation, submission and follow-up activities in Belgium.
- Provide administrative support for RA processes for The Netherlands and Belgium, including coordination of approval process for the Essential Information and handling of parallel distribution samples. This also includes some general administrative tasks, such as support with financial processes.
Patients first At Bayer Pharmaceuticals, we are passionate about shaping the future of patient care. By focusing on prescription products in cardiology and women’s health, we propose new treatments for cardiovascular diseases and drive innovation for women. By concentrating on specialty therapeutics in the areas of oncology, hematology and ophthalmology, we fight cancer, treat hemophilia and protect vision. Our mission is to research, develop, manufacture and market specialized products that improve the health of people throughout the world. Are you just as committed, focused and passionate as we are about shaping the future of health care?
**WHO YOU ARE**
- You have a university degree in life science or other relevant university degree, and 0 to 2 years working experience
- You have great communication skills, a flexible personality and a hands-on approach
- You have a high degree of accuracy and reliability
- Basic knowledge of drug development processes and a basic understanding of the local and regional drug regulatory landscape would be a plus
- You are fluent in both English and Dutch. In addition, command of the French language would be a plus.
**WHAT BAYER OFFERS YOU**
As a modern employer, we take care of our employees and help them find a balance between career development opportunities and personal life planning. We offer our employees a wide range of career prospects, a modern working environment and competitive compensation. Bayer employees benefit from great employment conditions, such as:
- An excellent competitive salary based on a 40-hour workweek
- An additional 8% holiday allowance, year-end premium, and a bonus (based on company results)
- 34 days of leave, of which 5 are reserved for days the office is closed
- Parttime work is possible from 36 hours per week
- Flexibility in working from home
- A solid retirement plan and bicycle lease plan
- An inspiring working environment with professional and committed colleagues
- A successful innovative organization with local and international career possibilities
- Challenges and possibilities to learn and to develop
- For this position, we offer a one-year contract, with a possibility for prolongation if there would be a further need within the company.
Please note, the above conditions are specifically for the NL. For BE there are some slight differences in the benefits.
Be innovative, be Bayer. We shape the future of everyday health, patient care and agriculture. Together, we can advance health and nutrition for all. Guided by our purpose ‘science for a better life’, rooted in our LIFE-values and steered by the organization’s strategy, we reach for our ambitious vision. Help bring this vision to life: Health for all, hunger for none.
LI-BNL
**YOUR APPLICATION**
Do you want to work in a place where you can be just YOU?
Your unique personality, background and talents help build a strong, diverse and inclusive Bayer.
So join us Be You, Be Bayer.
**Location**:
Belgium : Belgium : Diegem || Netherlands : Netherlands : Hoofddorp
**Division**:
Pharmaceuticals
**Reference Code**:
747361
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