Interim Regulatory Affairs officer
ARQ. Recruitment Group - Amsterdam
Interim Regulatory Affairs officer gezocht voor een middelgrote chemie organisatie in Arnhem e.o. – 24-32 uur per week, per direct – hybride – Minimaal 6 maanden+In deze functie ben je onderdeel van de afdeling QHSE - Volledige vacature bekijken
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Regulatory Affairs Consultant
Oxford Global Resources - 13-09-2022
Naar vacature
Are you an experienced Regulatory Affairs Consultant willing to work within a pharmaceutical company specialized in OTC medications, food supplements, cosmetics and other healthcare products ? Apply now to know more about this exciting opportunity !
Job Description
As an Regulatory Affairs Consultant, you carry out all regulatory actions to obtain and maintain licenses/registrations to commercialize products, within the defined timelines and in accordance with the applicable regulations.Responsibilities
- Preparing, drafting, submitting (possibly in collaboration with external partners) and following up the registration dossiers in accordance with the applicable guidelines.
- Performing all necessary actions required to maintain the licenses/registrations (variations, renewals, notifications, PSUR, …).
- Formulate proposals to the RA Manager about the possible approach and planning of the registration procedure.
- Coordinating the registration procedure in the countries involved, after validation of the working method and planning by the RA Manager.
- Analysis of the regulatory impact of changes to existing products. This includes changes to the quality part (production, analysis, specifications, APIs/raw materials, etc), as well as the clinical part (indications, side effects, claims, etc) of the dossier.
- Following the legislation and detailed regulatory and scientific guidelines in the countries concerned for products with different legal statuses.
- Answer the questions asked for certain products by the relevant authorities, pharmacists, doctors or customers, after internal and/or external consultation and validation by the RA Manager.
- Prepare impact analysis in response to changes in applicable regulations and formulate proposals and recommendations to ensure compliance.
- Checking and approving all packaging material and checking (and possibly notifying) advertising and promotional material.
Requirements
- Master's degree in a scientific field such as pharmaceutical sciences (pharmacist), drug development, biomedical sciences, bioengineering, (bio)chemistry or similar.
- Several years of RA experience in a pharmaceutical company, specifically in medicinal - food supplements.
- You are familiar with the different stages of drug development and production in a pharmaceutical company.
- You have a good knowledge of the relevant national, European and international legislation, procedural regulations and technical rules for products with different legal statuses.
- Able to work independently and in an organized manner.
- Excellent sense of priorities and accuracy
- Flexible and ability to adapt to changing circumstances/needs.
- You stay informed of developments in the field.
- Your speak Dutch and English. French is a plus.
- Good knowledge of Word, Excel and Outlook
- You have experience with local authorities in Belgium (FAMHP) & Luxembourg (Ministère de la Santé)
- The existing right to work in Europe
Benefits
- A balanced salary package based on your capabilities and experience
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