Senior Regulatory Affairs Associate — Remote

PE Global; Cambridge; Hybrid; GBP 44,000 - 59,000; Full time

Job summary

PE Global is seeking a Senior Associate Regulatory Affairs in Cambridge to support one or more products, under supervision of an experienced Regulatory Lead. The role is 12 months with potential extension, and offers PAYE or Umbrella pay options with hybrid working from home and monthly team meetings in Cambridge.

Key duties include planning regulatory submissions, aligning local requirements with company standards, providing input to regulatory strategies, and ensuring compliance with local

Qualifications

• Master’s degree (scientific area) or Bachelor’s degree (scientific area) with 2 years of directly related experience.
• Knowledge of Regulatory principles.
• Working with policies, procedures and SOPs.
• Understanding of drug development and how regulatory activities impact projects.

Responsibilities

• Assist in aligning local regulatory requirements with company standards.
• Provide input to, and execute regulatory strategies at national/regional level.
• Plan and manage local regulatory submissions in line with corporate standards and local requirements.
• Guide on mechanisms to optimise product development and regulatory approvals.
• Ensure local labels comply with legislation and company standards.

Skills

Regulatory affairs

Regulatory submission planning

Communicate scientific information

UK regulatory knowledge

Education

Master’s degree in a scientific field

Bachelor’s degree in a scientific field

Job description

PE Global is seeking a Senior Associate Regulatory Affairs in Cambridge to support one or more products, under supervision of an experienced Regulatory Lead. The role is 12 months with potential extension, and offers PAYE or Umbrella pay options with hybrid working from home and monthly team meetings in Cambridge.

Key duties include planning regulatory submissions, aligning local requirements with company standards, providing input to regulatory strategies, and ensuring compliance with local