Remote-Eligible Regulatory Affairs Manager (Europe)

Kroes Communications; Cambridge; Hybrid; GBP 125,000 - 150,000; Full time

Job summary

A global biopharmaceutical company in Cambridge is seeking a Regulatory Affairs Manager to ensure compliance with regulatory requirements for clinical trials and product approvals. You will be responsible for managing submissions and developing regulatory strategies in collaboration with the team. The ideal candidate should have a scientific degree, strong communication skills, and experience in regulatory environments. This role offers flexibility to work from home with some days in the office.

Benefits

Growth opportunities

Diverse and inclusive community

Generous total rewards plan

Qualifications

• Demonstrated experience in a similar role.
• Experience working with policies, procedures and SOPs.
• Experience in the regional regulatory environment.

Responsibilities

• Ensure that Amgen acquires and maintains required licenses for clinical trials.
• Support regulatory submissions for products.
• Participate in developing regional regulatory strategies.

Skills

Strong communication skills

Knowledge of regulatory principles

Ability to understand scientific/clinical information

Ability to anticipate and prevent potential issues

Education

Scientific degree

Job description

A global biopharmaceutical company in Cambridge is seeking a Regulatory Affairs Manager to ensure compliance with regulatory requirements for clinical trials and product approvals. You will be responsible for managing submissions and developing regulatory strategies in collaboration with the team. The ideal candidate should have a scientific degree, strong communication skills, and experience in regulatory environments. This role offers flexibility to work from home with some days in the office.