Senior Regulatory Affairs Associate

PE Global; Basingstoke; On-site; GBP 42,000 - 52,000; Full time

Job summary

PE Global is recruiting a Senior Regulatory Associate for a leading global pharmaceutical organisation. The role covers the UK, Ireland and Malta affiliates, managing regulatory operations and post-approval activities.

You will support regulatory plans, new product registrations, line extensions and labelling, ensuring compliance with local regulatory and quality requirements. Significant labelling experience is essential for this position.

Qualifications

• Bachelor's degree in a relevant scientific subject.
• At least one year of experience in Regulatory Affairs.
• Significant pharmaceutical labelling experience is essential.
• Experience with external regulatory agencies and an understanding of the healthcare environment.
• Knowledge of quality systems.

Responsibilities

• Execute the Regulatory Plan in alignment with affiliate business objectives and local regulatory requirements.
• Prepare and support regulatory applications for new marketing authorisations, line extensions and other regulatory submissions.
• Support timely responses to requests from regulatory authorities and internal support functions.
• Maintain existing marketing authorisations, including renewals, variations and periodic reporting activities.
• Track regulatory changes, assess their impact and communicate requirements across relevant internal teams.
• Support product launch teams by identifying regulatory considerations and helping deliver launch plans.
• Represent Regulatory Affairs within cross-functional brand teams and New Product Planning discussions.
• Maintain regulatory tools, trackers and metrics in line with compliance requirements.
• Facilitate interactions with regulatory bodies and support relationships with relevant regulatory agencies and trade associations.
• Act as Primary, Delegate or Alternate Affiliate Labelling Responsible Person (ALRP), as required.
• Ensure product information complies with local regulatory requirements.
• Coordinate the timely submission, approval and implementation of product information.
• Work in accordance with global labelling procedures and appropriately document exceptions.
• Ensure accurate, high-quality labelling is aligned with global core labelling requirements.

Skills

Regulatory planning

Labelling experience

UK & Ireland regulatory

Communications with authorities

Education

Bachelor's degree in a scientific subject

Job description

PE Global is currently recruiting for a Senior Regulatory Associate on behalf of a leading global pharmaceutical organisation.

• Position: Senior Regulatory Associate
• Contract: Initial 12-month contract

Role Overview

The Senior Regulatory Associate will be responsible for managing the operational and technical aspects of regulatory affairs across the UK and Ireland marketing affiliate, as well as the Maltese marketing affiliate.

The role will support the execution of regulatory plans, new product registrations, line extensions, indications and post-approval activities, while ensuring compliance with local regulatory and quality requirements.

Significant labelling experience is essential for this position.

Key Responsibilities

• Execute the Regulatory Plan in alignment with affiliate business objectives and local regulatory requirements.
• Prepare and support regulatory applications for new marketing authorisations, line extensions and other regulatory submissions.
• Support timely responses to requests from regulatory authorities and internal support functions.
• Maintain existing marketing authorisations, including renewals, variations and periodic reporting activities.
• Track regulatory changes, assess their impact and communicate requirements across relevant internal teams.
• Support product launch teams by identifying regulatory considerations and helping deliver launch plans.
• Represent Regulatory Affairs within cross-functional brand teams and New Product Planning discussions.
• Maintain regulatory tools, trackers and metrics in line with compliance requirements.
• Facilitate interactions with regulatory bodies and support relationships with relevant regulatory agencies and trade associations.
• Act as Primary, Delegate or Alternate Affiliate Labelling Responsible Person (ALRP), as required.
• Ensure product information complies with local regulatory requirements.
• Coordinate the timely submission, approval and implementation of product information.
• Work in accordance with global labelling procedures and appropriately document exceptions.
• Ensure accurate, high-quality labelling is aligned with global core labelling requirements.

Regulatory Compliance

• Ensure regulatory systems, IT tools and trackers are accurate and maintained up to date.
• Ensure products comply with applicable local regulations and quality system requirements.
• Maintain complete and accurate regulatory archives, including current licences and approved labels.
• Support internal audits, assessments, self-inspections and external inspections.

Requirements

• A bachelor's degree or equivalent qualification in a relevant scientific subject.
• At least one year of industry experience within Regulatory Affairs.
• Significant pharmaceutical labelling experience - essential.
• Experience working with external regulatory agencies and an understanding of the healthcare environment and commercial requirements.
• Knowledge of quality systems.

Please note PE Global cannot provide visa sponsorship for this role. Candidates will need the full right to live and work within the UK for at least the next 12 months.