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Regulatory Affairs Manager

JR United Kingdom

Reading

On-site

GBP 45,000 - 75,000

Full time

8 days ago

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An established industry player is looking for a Regulatory Affairs Manager to join their dynamic team in Berkshire. This role involves implementing regulatory strategies for a diverse portfolio of products, ensuring compliance with European guidelines, and liaising directly with the EMA. The ideal candidate will have significant experience in the pharmaceutical sector, particularly in regulatory affairs, and will be adept at navigating complex environments. With a highly competitive salary, car allowance, and comprehensive benefits, this position offers a fantastic opportunity to make a meaningful impact in the pharmaceutical landscape. If you are passionate about regulatory affairs and ready to take the next step in your career, this role is perfect for you.

Car Allowance

Annual Bonus

Private Healthcare

Wider Benefits

Experience in Regulatory Affairs within the pharmaceutical industry is crucial.
European regulatory experience is essential for this role.

Implement regulatory strategies for drug development and marketed products.
Liaise directly with EMA and ensure compliance with regional guidelines.

Regulatory Affairs

Pharmaceutical Industry Experience

Organizational Skills

Cross-Cultural Communication

A Top 10 Pharmaceutical company in Berkshire are seeking a Regulatory Affairs Manager to join their team. In this role you will implement regulatory strategies & deliverables for a portfolio of early/late development and marketed products in Europe.

Responsibilities:

Implement regulatory strategies & deliverables including effective planning, tracking, archiving of activities, especially submissions for early/late development and marketed products in the assigned Therapeutic Area.
Responsible for ensuring planned drug development activities comply with Europe Region guidelines and in cases where they do not provides a critical analysis of the risks and issues.
Supports the drug development strategy; defining options for Scientific Advice/Peadiatric Investigation Plan, creating briefing packages and co-ordinating and leading agency meetings.
Responsible for direct liaison with EMA for products within the Therapeutic area.

Requirements:

Pharmaceutical industry experience in Regulatory Affairs.
European regulatory experience is essential.
Experience of Neuroscience products is beneficial.
Experience working effectively across cultures and in complex matrixed environment.
Excellent organizational skills and highly motivated.

Salary and benefits:

A highly competitive salary, car allowance, annual bonus, private healthcare and wider benefits are on offer.

To apply for this position or hear further details then please click “Apply” or reach out via email.

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