Regulatory Affairs Associate

For one of our clients located in Brussels, we are looking for an experienced and enthusiastic RA Associate.

  • Do you have a bachelor degree in Life Science?
  • Do you have at least 2 years of experience in Regulatory Affairs at a national or regional level in the pharmaceutical industry?
  • Are you fluent in English (oral and written)?

Then you might be the candidate we are looking for. Don't hesitate and apply now!

Job Description 

Our client's project is notably to promote the distribution of vaccines and pharmaceutical products in Africa. In the framework of this project, as a Regulatory Affairs  Associate, your main role is to assist the RA Manager and to provide regulatory support to colleagues in the African Markets.

Responsibilities 

1. You provide operational support in product registration and maintenance for African markets (Uganda, Nigeria and Ethiopia):

  • New Market Introductions

- Preparation of product dossiers, supporting documents (certificates) and responses to questions
- Submission and follow-up of Market Addition Requests
- Submission and follow-up of requests for registration dossiers, certificates and product samples
- Compilation, translation and submission of registration dossiers, including payment of fees
- Submission and follow-up of requests for responses to questions and additional information
- Preparation and/or approval of product labels and package inserts
- Archiving of regulatory documents, submissions, queries, approvals and correspondence, in accordance with the requirements

  • Registration maintenance

- Request dossiers, certificates and product samples required for registration renewal
- Submission and follow-up of dossiers, certificates and product samples required for registration renewal, including payment of fees
- Submission and follow-up of dossiers, certificates and product samples required for registration variations, including payment of fees
- Compilation and translation of renewal and variation dossiers, as necessary
- Submission and follow-up of requests for responses to questions and additional information
- Archiving of regulatory documents, submissions, queries, approvals and correspondence, in accordance with the requirements

  • Support of marketed products

- Initiation and approval of changes to product labels and package inserts
- Review and approval of advertising and promotional materials, as it concerns compliance with the product registrations and local regulations
- Reporting of all pharmacovigilance cases in accordance with our client's Global Regulatory Affairs requirements
- Ensure manufacturing site GMP status meets the requirements of each market
 

2. You provide operational support of the Geographic Expansion Process for markets in Europe, Africa and the Middle East as required:

  • Ensuring understanding of, and adherence to process steps and timelines by all stakeholders
  • Ensuring completeness and accuracy of entries made in the Geographic Expansion Wish List, Assessment and Tracking system
  • Provision of regulatory documents to markets, in accordance with their needs and the agreed timelines
  • Archiving of regulatory documents, submissions, queries, approvals and correspondence, in accordance with the requirements

3. You use global systems to respond to queries and generate status reports​

Profile 
  • You have a bachelor degree in Life Science or equivalent experience.  
  • You have at least 2 years of experience in Regulatory Affairs at a national or regional level in the pharmaceutical industry
  • You have a strong experience in using MS Word, Excel (especially) and PowerPoint
  • You are fluent in English (oral and written)You have a strong knowledge of Excel
  • You are multi-task and you have strong planning and organization skills
Contact Information 

Amandine Planche
010/68.53.30
amandine.planche@valesta.com

Application form : Regulatory Affairs Associate

Files must be less than 3 MB.
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Files must be less than 3 MB.
Allowed file types: txt rtf html pdf doc docx odt.

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