Senior Regulatory Affairs Associate

Our client, a global pharmaceutical company, is currently looking for a Senior Regulatory Affairs Associate to join their team in Uxbridge. 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 in CMC regulatory affairs
• 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.