Senior Regulatory Affairs Associate

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 currently recruiting for a Senior Associate Regulatory Affairs for a leading multi-national Pharma client based in Cambridge.

This is an initial 12 months contract position with potential for extension.

Pay rate is £22.33ph PAYE or £30.13ph Umbrella.

Working mainly from home but would be expected to go in for team meetings (once a month in Cambridge).

The Senior Associate Regulatory Affairs is assigned to one or more company products and may support an LRR or lead the planning and execution of Regulatory strategies for a program(s) under the supervision of an experienced Regulatory Lead.

Duties of the role/Responsibilities

• Assist in aligning local regulatory requirements with company’s corporate standards.
• Provide national/regional (as applicable) input to and execute regulatory strategies.
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Provide guidance on local mechanisms to optimize product development and regulatory approvals
• Ensure local labels are developed and maintained in line with local legislation and company standards and procedures.
• Ensure and support local regulatory product compliance (eg, IMR, PMCs, and agency commitments)
• Act as the point of contact with regulatory agencies.
• Ensures regulatory submissions are made on time and meet company’s corporate and local regulatory requirements.
• Creates, reviews, and approves source text for country labeling, and owns the country artwork based on source text.
• Collaborates with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate).
• Reviews and approves the promotional and non-promotional materials
• Monitors the external regulatory environment to help inform/advise in the regulatory decision making.

Education/Experience

• Master’s degree (scientific area) OR
• Bachelor’s degree (scientific area) and 2 years of directly related experience
• Knowledge of Regulatory principles.
• Working with policies, procedures and SOP’s.
• Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
• General knowledge of national legislation and regulations relating to medicinal products.
• Understanding of drug development.
• Ability to understand and communicate scientific/clinical information.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***