Regulatory Strategy Lead — Trials & Market Approvals

Meeveem Limited; Uxbridge; On-site; GBP 41,754 - 56,492; Full time

Benefits offered by this job

Growth opportunities

Diversity & inclusion

Total rewards plan

Job summary

Amgen is seeking a Regulatory Affairs Manager to lead regulatory submissions and regional strategy for its portfolio. You will coordinate cross-functional teams to ensure compliance with global and local requirements and optimize regulatory paths for trials and marketed products.

The role requires strong knowledge of regional regulations, excellent communication skills, and the ability to anticipate regulatory risks and issues in a dynamic environment.

Qualifications

• Scientific degree and demonstrated experience in regulatory roles.
• Knowledge of legislation and regulations relating to medicinal products.
• Experience with regional regulatory environments and drug development.

Responsibilities

• Plan and manage regulatory submissions for products within Amgen's portfolio.
• Implement product-related regulatory strategies and activity planning per national/regional requirements.
• Provide content guidance for regional regulatory documents and meetings.
• Support regional label negotiation activities.
• Develop and execute regional regulatory product strategies.
• Assess regulatory risks and forecast potential outcomes.

Skills

Regulatory affairs

Communication skills

Drug development

Regulatory principles

Education

Scientific degree

Job description

Amgen is seeking a Regulatory Affairs Manager to lead regulatory submissions and regional strategy for its portfolio. You will coordinate cross-functional teams to ensure compliance with global and local requirements and optimize regulatory paths for trials and marketed products.

The role requires strong knowledge of regional regulations, excellent communication skills, and the ability to anticipate regulatory risks and issues in a dynamic environment.