Junior Regulatory Affairs - Spain
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- Requesting / Archiving/ Provision of Official Certificates.Samples required to support submissions.
- Dossier compilation from the Regulatory Tracking Tool.Shipment and archiving of original documents
- Provide administrative regulatory support for Chemistry
- Manufacturing Control registration submissions of products / contract manufacturers.
- Consult Regulatory Database for information of the requirements of the countries to assure an adequate support.
- Tracking of on going regulatory activities to ensure:Appropriate follow-up of on-going activities with company Affiliates (submissions and approvals). Run monthly reports to identify upcoming activities.
- Keep the Manufacturing Site Regulatory Affairs Fields up to date (Planned Submission Month, Support Status, etc)
- Keep the List of Countries in date base updated
- Review Good Manufacturing Practices documentation to ensure compliance with current regulatory commitments,
- Ensure all coporate policies related to health, safety and environment are understood and followed in relation to the role.
- Subject Matter Expert on the legalization and consularization of documents.
Education and Experience
- Graduate in Chemistry, Pharmacy or other background in life science.
- Exemplary English oral and written communication skills (C1/ Advanced or equivalent).