Вакансия находится в АРХИВЕ.

Regulatory Affairs Specialist / Специалист по регистрации ЛС

Москва

Our client is an international pharmaceutical company (TOP - 3).

Responsibilities:

  • Writing and changing of local labels:
  1. Prepare labels for new products based on the Company Core Data Sheet - CDS (EU Summary of Product Characteristics - EU SmPC, US Product information - USPI if needed) in line with the requirements: local Product Information (PI) under national level, SmPC and PI under Eurasian Economic Union (EAEU) level;
  2. Prepare label updates for approved products based on the CDS (EU SmPC, USPI, local business request if needed) in line with the requirements: local PI under national level, SmPC and PIL under EAEU level;
  3. Lead the label negotiation process with HQ;
  4. Align deviations from CDS HQ via DART system proving appropriate rationales;
  • Participate in CDS development for New Products and New Indications from Affiliate perspective;
  • Prepare clinical and preclinical parts of the dossier for the new products registration based on the dossier received from HQ in line with local requirements;
  • Prepare supporting package for label updates;
  • Explanatory notes creation for preclinical & clinical & PI part (local specific document which is crucial to result in the positive approval and/or timely approval);
  • Translation verifications of registration dossier documentation
  • Prepare product renewals locally;
  • Prepare responses to HA requests in collaboration with HQ;
  • Responsible for GPRS-PID system for product labels in Russia: manage process details, submissions, approvals, deviations, content;
  • Create and agree with HQ and relevant Chapters the local regulatory strategies and timelines for New Products, New Indications;
  • Dedicated Franchises/SQUADs Extended Team member;
  • User testing coordination for PIs prepared in the frames of EAEU.

Qualifications:

  • University degree.

  • Experience in a pharmaceutical company (regulatory affairs - preferable).

  • Russian speaker and business level fluency in English.

Benefits:

  • Annual bonus.

  • Voluntary health insurance.

  • Meal allowance.
  • Car allowance.

16 марта 2023
31 марта 2023
От 1 года до 3 лет

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