Senior Regulatory Affairs Manager

A global pharmaceutical company, based in Cambridge, is currently looking for a Senior Regulatory Affairs Manager to join their team on an initial 12-month contract. 

You will be a confident Regulatory Lead looking to work in an innovative therapy area such as endocrinology, inflammatory as well as oncology, developing and defining regulatory plans across multiple products. Taking ownership of end to end regulatory life cycle for 1-2 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.

Other responsibilities include:

• 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

Requirements

• 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 and MAAs is 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.