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Senior Regulatory Affairs Associate (Global Labelling)

Parexel International Corporation

Romania - Any Region - Home Based

We are currently looking for a Senior Regulatory Affairs Associate to join our Consulting team in Romania. This function will hold the following responsibilities:

Act as Global Labelling Operations Manager and be responsible for supporting the development and update of core labelling documents and for tracking implementation at a local and regional level.

Tasks will involve the following: Create and update core labelling documents, CCDS updates, change control assessment Oversee regional implementation Core labelling support documentation Maintain labelling compliance QualificationsIdeal candidate will possess: 3-5 years pharmaceutical/biotechnology industry experience, in regulatory affairs Relevant experience with EU variations, including assessment and classification Growing knowledge and understanding of applicable regulations Good understanding of pharmacology, medicine, pharmacovigilance and drug development is needed Proven experience with document management and regulatory tracking systems Very good understanding of performing the above regulatory tasks on global or EU level Fluent English Project Management skills Strong organizational and time management skills Strong communication and oral skills (F2F and virtual/TC)

Job posted: 2021-11-13

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