Sr. Associate Regulatory Affairs
SIRE Life Sciences®
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SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Pharmaceutical and Biotechnology organisation, based in City of London United Kingdom.
The CompanyOur client is currently seeking a Sr Associate Regulatory Affairs to join their UK affiliate, located in the greater London area.
Role DescriptionThe Regulatory Affairs Sr. Associate will be responsible for local coordination and execution of regulatory submissions in compliance with corporate standards and local regulatory requirements.
Responsibilities- Ensure regulatory submissions are made on time and meet our clients corporate and local regulatory requirements
- Contribute to and execute the filing plan
- Review source and artwork text for country labelling
- Maintain an awareness of & ensure local management are kept up to date on new & developing local legislation & regulatory policy
- Participate in local regulatory process improvements initiatives
- Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis
- Provide advice on local regulatory considerations in a timely manner
- Coordinating translation for local Regulatory submission
- Review promotional & non-promotional review
- Partner where required with European Regulatory Leads (EU RLs) to support the regulatory development, registration, and life-cycle management of all our clients molecules Basic
Requirements- Masters degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum, OR
- Bachelor’s degree in a science discipline (biology, life science, health science) and 2 years of directly related experience
- Relevant regulatory experience
- Good communication skills - both oral and written
- Ability to understand and communicate scientific/clinical information
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.