Global Regulatory Compliance Director
4 days ago
Job Summary:
We are looking for a Senior Regulatory Affairs Manager to join our client's team in Uxbridge. The role involves developing and implementing regulatory strategies to ensure compliance with global regulatory requirements.
The ideal candidate will have experience as a Regulatory Lead managing at least 1 product end to end lifecycle and be able to clearly demonstrate experience in developing centralised regulatory plans and strategy.
Key responsibilities include:
- Developing, contributing and ensuring the accurate preparation of high-quality regulatory documents needed to support clinical trials and medical products.
- Contributing regulatory guidance to enhance product development.
- Sitting with the wider project team, providing guidance on how regulatory strategy should be implemented.
- Ensuring that product development is aligned with the company's strategy business model as well as global regulatory requirements.
- Acting as a point of contact between the company and regulatory agencies whilst pertaining important information.
Salary: £100,000 - £130,000 per annum.
Requirements:
- Proven experience as a Regulatory Lead managing at least 1 product end to end lifecycle.
- Experience in developing centralised regulatory plans and strategy.
- Strong communication and stakeholder management experience.
- Previous experience in Regulatory Affairs particularly within the pharmaceutical industry.
- Centralised Regulatory Affairs experience.
- Strong strategic experience within Regulatory Affairs.
- Exposure to Regulatory Affairs full cycle and submissions procedures such as CTA, PIPs, ODDs, and MAAs is advantageous.
- Exposure of Regulatory Affairs legislation and procedures.
- Strong communication and interpersonal skills.
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