Regulatory Compliance Expert
1 dzień temu
We are seeking a highly skilled Regulatory Specialist to support our operational activities related to the maintenance of marketing authorisations across assigned markets and/or submission types in European Partnership Markets.
This role will involve working closely with country leads, global regulatory teams/centers, and local 3rd party service providers to ensure compliance with regulatory requirements.
The ideal candidate will have a strong understanding of regulatory processes related to license maintenance and experience working in a matrix organization or international environment.
A minimum of 2 years of relevant experience in regulatory affairs and pharmaceutical industry is required.
- Supporting country leads in activities related to maintenance of marketing authorizations (MAs) for assigned markets and/or submission types across pharma and vaccines portfolio.
- Providing inputs and support to planning and tracking of regulatory activities for defined markets/submission types.
- Managing routine operational steps within Regulatory Information Management (RIM) systems related to the local activities within end-to-end regulatory processes, including data assessments.
- Master's/Bachelor's degree in scientific discipline (life sciences/pharmacy/professions aligned to medicine).
- Approximately 2 years of relevant experience in regulatory affairs and pharmaceutical industry.
- Understanding of the pharmaceutical industry and regulatory processes related to license maintenance.
- Awareness of policies and regulatory climate in Europe.
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