Senior Manager/Director of Regulatory Affairs

3 weeks ago

United Kingdom Park Street People Full time

A global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team.
You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products.
This is a great opportunity to work with a team who take provide in working to the highest standards, passionate about delivering excellence and focused on sharing regulatory best practice and guidance throughout the wider business.
Working with the regulatory team (and core stakeholders across multiple areas), your role will be to operate as a Regulatory Lead, providing centralised regulatory strategy and guidance across the region and make sure that regulatory deadlines and approvals are achieved.
You will develop, contribute and ensure the accurate preparation of high-quality regulatory documents needed to support clinical trials and medical products.
Contributing regulatory guidance in order to enhance product development
As the regulatory lead, you will sit 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
Proven experience as a Regulatory Lead managing at least 1 product end to end lifecycle
You will be able to clearly demonstrate experience in developing centralised regulatory plans and strategy
Strong communication and stakeholder management experience, you will be able to demonstrate working in project teams, where you have guided/advised on the implementation of your strategy/regulatory plan
Previous experience in Regulatory Affairs particularly within 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
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.

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