Regulatory Affairs Manager

JR United Kingdom; Doncaster; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company is seeking a Regulatory Affairs Manager to oversee regulatory activities across the UK and Ireland. This role involves ensuring compliance with UK legislation, supporting drug launches, and maintaining relationships with regulatory authorities. The ideal candidate will have over five years of experience and a proven track record in the pharmaceutical industry.

Qualifications

• 5+ years of experience in regulatory affairs in pharmaceuticals.
• Expert knowledge of UK regulatory processes.
• Ability to manage multiple priorities in fast-paced environments.

Responsibilities

• Manage regulatory activities for the UK and Ireland.
• Liaise with regulatory authorities.
• Support the launch of innovative drugs.

Skills

Communication

Organizational skills

Regulatory expertise

Job description

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Regulatory Affairs Manager - Pharmaceuticals

As the Regulatory Affairs Manager for the UK and Ireland, you will provide expert regulatory guidance to our UK organization and manage all regulatory activities across the UK and Ireland. Additionally, you will serve as the Local Person for Pharmacovigilance (LPPV) and the National Pharmacovigilance Contact Person.

We are a dynamic and innovation pharmaceutical company, dedicated to bringing groundbreaking therapies to markets. With several exciting drug launches planned over the next 24 months, we are looking for a dedicated and experienced Regulatory Affairs Manager to join our team.

Key Responsibilities:

• Provide UK regulatory expertise to the organization.
• Manage regulatory activities for the UK and Ireland.
• Serve as the LPPV/National Pharmacovigilance Contact Person.
• Ensure compliance with UK regulatory processes and national drug legislation.
• Support the launch of innovative drugs over the coming years.
• Liaise with regulatory authorities and maintain up-to-date knowledge of regulatory requirements.

Qualifications:

• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
• Expert knowledge of UK regulatory processes and national drug legislation.
• Strong communication and organizational skills.
• Ability to work in a fast-paced environment and manage multiple priorities.
• Proven track record of successful regulatory submissions and product launches.