Remote Regulatory Affairs Leader — Biotech Innovations

Amgen; Uxbridge; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A global biotechnology company based in Uxbridge is seeking an experienced Regulatory Affairs Manager to ensure proper licenses for clinical trials and marketing products. The role involves managing regulatory submissions, providing guidance on regional regulations, and working with a team on product strategy. Ideal candidates will have a scientific degree and experience in a similar regulatory role.

Benefits

Growth opportunities

Diverse community

Generous Total Rewards Plan

Qualifications

• Demonstrated experience in a similar regulatory role.
• Knowledge of legislation and regulations related to medicinal products.
• Awareness of registration procedures for clinical trials and marketing approvals.

Responsibilities

• Ensure Amgen acquires and maintains licenses for clinical trials and products.
• Plan and manage regulatory submissions in compliance with requirements.
• Provide guidance on regional regulatory mechanisms for product development.

Skills

Scientific Degree

Regulatory principles

Knowledge of drug development

Regional regulatory environment experience

Strong communication skills

Ability to understand scientific information

Conflict resolution

Education

Scientific Degree

Job description

A global biotechnology company based in Uxbridge is seeking an experienced Regulatory Affairs Manager to ensure proper licenses for clinical trials and marketing products. The role involves managing regulatory submissions, providing guidance on regional regulations, and working with a team on product strategy. Ideal candidates will have a scientific degree and experience in a similar regulatory role.