Regulatory Affairs Associate (Administrative)
Our company is a global pharmaceutical company, part of the Softgel Business Unit, within Thermo Fisher Tilburg. We develop different pharmaceutical products as soft gel capsules for our own product portfolio and for the customers.
Regulatory Affairs department is a dynamic and highly skilled team, who is part of Research & Development organization. We provide regulatory support to the customers and team members related to different regulatory topics. We are setting up a bioequivalence studies, writing and reviewing of the regulatory documents, compilation and submission of the dossiers in EU and US. Furthermore, we maintain the approved dossiers through the whole life cycle.
We are looking for a professional who is flexible and can help coordinate customers inquiries, maintain documentation and build databases. Within our department you will provide support and assistance related to regulatory documents, archiving and maintenance of different databases.
Thermo Fisher Scientific in the Netherlands. https://jobs.thermofisher.com/global/en/netherlands
Thermo Fisher Scientific Company Video https://www.youtube.com/watch?v=fsDWobfow9c
How will you make an impact?
You will be supporting us with administrative tasks by collecting, keeping up to date and archiving of the documents needed for the regulatory submissions. Regulatory Affairs team exists of 4 colleagues who report directly to our Sr Manager Regulatory Affairs.
What will you do?
Assist, build and help improve our departmental trackers and databases.
You will be aligning with the finance department and different regulatory agencies regarding the fee payment for all regulatory activities.
Collecting supportive documentation needed to create change control records upon request.
Constantly aligning with clients about e.g. GMP certificate, Certificates of Suitability (CEP) revisions, statements and other requests. Responsible for collection of the documentation for answering specific questions from customer and regulatory agency.
Supporting the answering regulatory questions from partners by collaboration with different teams.
This role is excellent for a candidate that is very knowledgeable with computers, is accurate and precise. Next to a very diverse work environment you have a lot of freedom in this role and you can share ideas. On top of that there is a lot of room for flexible work hours and working remotely, office versus at home. There is also a possibility to grow in a specific (electronic) documenting system and providing information to the regulatory agency.
How will you get there?
- Requires effective partnership, attention to detail, follow through and good organizational skills. Requires interaction with the operations personnel, finance department, Quality Control, Quality Assurance, R&D and clients.
- Minimal MBO level
- Excellent software skills such as Word, Excel, PowerPoint
- Good communication (in writing and verbal) in English and preferably Dutch.
What We Offer You?
Apart from strong benefits and salary conditions, flexible working conditions, we welcome candidates that enjoy working in a diverse, multi-cultural, multi-disciplinary, growing business environment where personal development and team cooperation are key to success.
Diversity in our teams is an important element to create an effective and challenging working environment. Integrity, Intensity, Innovation and Involvement are key characteristics that we expect of all that are part of our community.
- preferably Dutch.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.