Regulatory Affairs Specialist
4 weeks ago
We are seeking a highly skilled Senior Regulatory Affairs Associate to join our team at Park Street People Ltd. This is a fantastic opportunity to work with a global pharmaceutical company that values innovation and cutting-edge techniques in their science.
Key Responsibilities:
- Provide regulatory guidance across the EU region to ensure compliance with regulatory deadlines and approvals.
- Develop, contribute, and ensure the accurate preparation of high-quality regulatory documents needed to support clinical trials and medical products.
- Contribute regulatory guidance to enhance product development and ensure alignment with the company's strategy and global regulatory requirements.
- Act as a point of contact between the company and regulatory agencies, providing critical information and support.
Requirements:
- Previous experience in Regulatory Affairs and Compliance, particularly within the pharmaceutical industry.
- Proven background working on CTAs (clinical trial application) and MAAs (marketing authorisation application).
- Exposure to Regulatory Affairs legislation and procedures.
- Strong communication and interpersonal skills.
Pay Rate:
- PAYE = £23.70 basic + £3.43 holiday pay (£27.13 total)
- Umbrella = £31.13 per hour
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.
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