Sr. Regulatory Affairs Officer

Job Description

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 own product portfolio and for the customers.

Location Division

Regulatory Affairs department is a multidimensional and highly skilled team, who is part of Research & Development organization. We provide regulatory support to the customers and team members related to versatile topics. We are responsible for 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.

Thermo Fisher Scientific in the Netherlands. https://jobs.thermofisher.com/global/en/netherlands

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How will you make an impact?

We are looking for a client oriented professional, who can bring a positive can-do attitude and a focus on continuous improvement. Within our department you will play an instrumental role in supporting of the department by collecting and maintaining of documents according to the pharmaceutical regulatory requirements (following EU GMP, US FDA 21 CFR and ICH guidelines). Furthermore, preparing and submitting of the variations and the dossiers (in eCTD) to the agencies.

What will you do?

You will be supporting with RA tasks by collecting documents, writing and maintaining the documents needed for the regulatory submissions.

Complete relevant documentation in line with the GMP, company and pharmaceutical guidelines.

Responsible for preparing of the complete registration dossier (CMC, clinical and non-clinical part) and/or variations in-line with current guidelines and regulations.

Answering regulatory questions from partners (different departments within the company and regulatory authorities).

Initiate change control records and you are owner of the records having the responsibility for progress of the completed actions. Makes an RA assessment on the impact of the change and completes the actions following the change control.

Responsible for the bioequivalence study i.e. set-up of study in-line with guidelines, preparation of Investigational Medicinal Product Dossier (IMPD)/ Clinical Trial Application (CTA). Manage clinical vendors to conduct bioequivalence studies. Coordinate the labeling of study samples and purchasing of the Reference product (RLD)

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.There is also a possibility to grow in a project responsible role, where you will represent Regulatory Affairs as core team member responsible for the development of the new products.

Requirements

• Requires a passion for problem solving, attention to detail, good organizational skills, a sound understanding of GMPs and Manufacturing. Requires interaction with the operations personnel, Quality Control, Quality Assurance, R&D, agencies and clients.
• Minimal requires 5 years of experience in a position preferably in Pharmaceutical/ BioTech industry.
• Knowledge of the full dossier (writing and reviewing according to the EU guidelines) and preparation and submission of the variations (according to the EU guidelines).
• Knowledge of European national and MRP/DCP submissions. Knowledge of FDA legislation would be a bonus
• Knowledge of GMP, EP and US pharmacopeia
• Able to work with eCTD software and submissions
• Excellent planning skills and communication skills (writing and verbal) in English and 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.We welcome candidates that enjoy working in a diverse, multi-disciplinary, groundbreaking environment where personal development and team cooperation are key to success, to make the impossible - possible for our customers.

Diversity in our teams is an important element to build an effective and challenging working environment. Integrity, Intensity, Innovation and Involvement are key values that we expect of all that are part of our community.

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