Primary Responsibilities:Interact with global regulatory authorities (EMA and other EU/worldwide health authorities as necessary) to manage the lifecycle of on-market biosimilars. This involves the following...
The Regulatory Policy and Intelligence Consultant supports the RPI function by researching questions and areas of regulatory intelligence for assigned topics and regional area, including the interrogation and support of applicable databases of regulatory approval information. The Consultant should also be comfortable working in an environment where they can proactively bring forward new ideas and processes impacting their assigned projects.
Review and evaluate regulatory intelligence for assigned regions and topics.
Support business compliance through raising awareness of new requirements, by communicating to subject matter experts, quality compliance experts and other relevant colleagues.
Partnership role with affiliates for identification of significant national regulatory intelligence information, and communication to stakeholders
Support analysis of regulatory trends in the environment in key areas of interest
Conduct sophisticated searches of regulatory intelligence sources and present findings in a summary that can be communicated within the business
Conducts research to respond to regulatory policy and procedure questions received from colleagues in the business.
Life Sciences degree qualified.
Regulatory Certification an advantage
Strong working knowledge within Regulatory intelligence gathering and analysis.
Good understanding of Regulatory environment and Regulatory pathways.
Experience with, Word, PowerPoint, and Excel. Demonstrated competency in conducting primary research and distilling large amounts of information into concise executive summaries.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.