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Park Street People
,
Cambridge, Cambridgeshire
Senior Regulatory Affairs Associate
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Contract Type: Contract |
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Salary: £20 per hour |
Overview
Our client, a global pharmaceutical company, is currently looking for a Senior Regulatory Affairs Associate to join their team in Cambridge. This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their science. Key Responsibilities A key role in the creation and submission of regulatory documents, taking the lead as required Assist with regional regulatory pre-filing activities Assisting with developing the strategy and plans within the regulatory team Liaise with and build good relationships with CROs, regulatory agencies and other internal and external stakeholders Maintain an active awareness of EU and EEMEa Regulatory legislation QC and compliance responsibilities for submissions and filings Contribute to annual reports and investigator packages Requirements Previous experience in EU regional Regulatory Affairs and Compliance particularly within the pharmaceutical industry Experience with CTA applications and post authorisation submissions VHP knowledge advantageous Exposure of Regulatory Affairs legislation and procedures Strong communication and interpersonal skills Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.