Regulatory Affairs Manager

2 weeks ago


Harlow, Essex, United Kingdom IPHARM CONSULTING Full time
Job Title: Regulatory Affairs Manager

Location: UK

Contract Duration: 8 months (Inside IR35)

Pay Rate: £32 - £37 per hour

Work Structure: Monday to Friday, 7:30 AM – 3:30 PM

Our client, a leading pharmaceutical company, is seeking an experienced Regulatory Affairs Manager to oversee regulatory activities for the UK and Ireland, focusing on Marketing Authorisation Applications (MAAs) for New Chemical Entities (NCEs), medical devices, biosimilars, and OTC products. The role involves managing the full lifecycle of product approvals, from submission to launch, ensuring regulatory compliance and timely approvals.

Key Responsibilities:

• Lead and manage regulatory submissions and strategies for UK/IE MAAs.

• Ensure timely product approvals and manage post-approval obligations.

• Collaborate with cross-functional teams to support product development and in-licensing initiatives.

• Liaise with regulatory bodies to resolve challenges and ensure compliance.

• Mentor and train team members while staying updated on regulatory changes.

Requirements:

• Degree in Pharmacy, Chemistry, or Life Sciences.

• Strong background in Regulatory Affairs within the pharmaceutical industry, with significant experience in new submissions and post-approval activities.

• Demonstrated experience working with regulatory bodies.

• Proven expertise in regulatory strategy development and project management.

Preferred Skills:

• In-depth knowledge of medical device registration and Brexit-related requirements.

• Experience in CTAs, paediatric investigation plans, and orphan designations is highly desirable.

What We're Looking For:

If you are a motivated regulatory professional looking for a dynamic team and an opportunity to contribute to meaningful pharmaceutical projects, this could be the role for you.

How to Apply:

To apply, please submit your CV outlining your qualifications and experience relevant to this role.

Company Overview:

IPHARM CONSULTING is a leading pharmaceutical company seeking a Regulatory Affairs Manager to oversee regulatory activities for the UK and Ireland.

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