354 days ago on sire-search.com

Regulatory Affairs Officer - Pharma

SIRE Life Sciences

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Regulatory Affairs Officer - Pharma

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Biotechnology and Pharmaceutical organization, based in Basel-Stadt Switzerland.

Our client is focused on ear disorders.

ROLE DESCRIPTION

- Prepare and review regulatory documentation
- Coordinate and compile regulatory submission

RESPONSIBILITIES

- Support the handling of CTA procedures
- Support the handling of pre-authorization activities globally
- Support the handling of marketing authorization procedures and post-authorization activities globally
- Set up and maintain the submission/approval tracking databases
- Ensure regulatory compliance with global regulations, as well as with approvals

REQUIREMENTS

- University degree in life sciences (chemistry, pharmacy, biology or another life science)
- Minimum two years of international pharmaceutical industry experience or a regulatory affairs certification
- Ideally experience with eCTD, CP or regulatory product maintenance
- Strong analytical, organisational, and project management skills
- Open, team-oriented and communicative personality
- Fluent in written and oral English and German

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.