Regulatory Affairs Manager

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 Hessen Germany.

Our client is a multinational Pharma company

ROLE DESCRIPTION

- Point of contact to health authorities

RESPONSIBILITIES

- Ensure activities compliant to local regulatory requirements
- Registration and maintenance of regulatory dossiers
- Regulatory Strategy Development
- Regulatory Intelligence Management
- Regulatory Risk Assessments
- Focus is on European regulatory requirements
- Support/Advice teams in Development, Sales & marketing and Management with regards to regulatory requirements
- (re)write and maintain SOP's
- Collaborate with Market Access, Drug Safety, Supply Chain Management, Clinical Development, Quality Management

REQUIREMENTS

- University degree in Life Sciences (e.g. Chemistry, Pharmacy, Biology, Medicine)
- At least 5 years of experience
- Experience in Global/EU RA
- Fluency in English

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.