Regulatory Affairs Senior Manager

Park Street People; Greater London; On-site; GBP 60,000 - 80,000; Full time

Job summary

A global pharmaceutical company is seeking a Senior Regulatory Affairs Manager in Uxbridge. This role involves leading regulatory strategy and ensuring compliance across product lifecycles. Candidates should have significant experience in Regulatory Affairs and strong communication skills. Join a team dedicated to excellence and innovation in the pharmaceutical industry.

Qualifications

• Significant Regulatory Affairs experience within pharmaceutical industry.
• Proven experience as a Regulatory Lead managing product lifecycle.

Responsibilities

• Develop high-quality regulatory documents for clinical trials.
• Provide regulatory strategy guidance across multiple products.
• Act as a point of contact with regulatory agencies.

Skills

Communication

Stakeholder Management

Strategic Thinking

Job description

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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.

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

• Significant Regulatory Affairs experience within pharmaceutical industry - essential.
• Proven experience as a Regulatory Lead managing at least one product end to end lifecycle.
• Preferably significant EU regulatory affairs exposure.
• 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.
• 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.

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science and Other

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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