Sr. Regulatory Affairs Officer
Hal Allergy B.V. - Leiden (Nederland)
For our client, Hal Allergy B.V., we are looking for a Sr. Regulatory Affairs Officer.
In the role of Senior Regulatory Affairs Officer at HAL Allergy in Leiden, you will have a very diverse job, containing all aspects of RA.
Working in a team of 4, you will mainly focus on Portfolio management; preparation & submission of applications and Product development; participation in multidisciplinary project teams, review of dossier sections and dossier building for clinical studies.
You will obtain, renew and adapt marketing authorizations in line with HAL Allergy’s marketing policy. Perform regulatory activities for in-vivo diagnostics and therapeutics for immunotherapy and request and support clinical trial (applications). In Project teams you will adequately bring the Regulatory issues and position forward and undertake action where required.
- Compile full registration dossiers (Module 1 to 5) according to current demands in a way they can be submitted in the right format (electronically) to competent authorities;
- Maintain and adapt existing registration dossiers and accompanying documents;
- Submit request for dossier changes (variations) in countries where registrations exist or named patient allowances are mandatory;
- Prepare for national and international registration procedures;
- Respond to questions from competent authorities;
- Assess patient information texts and labels and labelling of products;
- Perform activities on behalf of the Labeling committee;
- Structure and maintain eCTD software and XEVMPD database.
Who we're looking for
For this role, we are looking for candidates with an academic education in (bio) science or pharmacy) and some years of experience in Regulatory Affairs. You have knowledge of biological or biotechnological products and product development.
- Adequate CMC experience and change management;
- Regulatory experience within clinical trials, phase 1-3;
- Adequate experience with eCTD publishing software docuBridge (Lorenz);
- Publishing knowledge and experience.
As a persen you are capable to function well within Project teams and be able to communicate adequately with Authorities. To make a success of this very diverse role, it is important you can multitask, take ownership and work accurately. Are you the self starter with a critical view of work we are looking for?
HAL Allergy is one of the European top players in the field of allergy immunotherapy and has an internationally leading role in the production of modified allergen extracts for both, therapeutic and diagnostic purposes. They focus on the development, production and distribution of allergen immunotherapies for the treatment and prevention of allergic diseases.
Since its foundation 1959, HAL Allergy grew to a well-established player in the AIT market with a highly competitive portfolio offering subcutaneous (SCIT) and sublingual (SLIT) products for pollen, house dust mites and insect venoms. Their GMP certified and state-of-the-art production facility is located in the Bio Science Park in Leiden, The Netherlands.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Contract for at least one year, extention possible.|
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|+31 (0)88 22 77 555|
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