Senior Regulatory Affairs Specialist — Labelling & Compliance (Hybrid)

PE Global International; Basingstoke; Hybride; GBP 30 000 - 40 000; Plein temps

Résumé du poste

PE Global International is seeking a Senior Regulatory Associate for a 12-month contract in Basingstoke. You will manage regulatory operations across the UK, Ireland and Malta, supporting new product registrations, line extensions, indications and post-approval activities while ensuring compliance with local regulatory and quality requirements.

Significant labelling experience is essential. You will collaborate with cross-functional teams, maintain regulatory tools and trackers, and liaise with

Qualifications

• Bachelor's degree in a relevant scientific subject.
• At least 1 year of industry experience within Regulatory Affairs.
• Significant pharmaceutical labelling experience is essential.
• Experience working with external regulatory agencies and healthcare environment knowledge.
• Knowledge of quality systems.

Responsabilités

• 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.

Connaissances

Regulatory affairs experience

Labelling experience

Quality systems knowledge

Formation

Bachelor's degree in a relevant scientific subject

Description du poste

PE Global International is seeking a Senior Regulatory Associate for a 12-month contract in Basingstoke. You will manage regulatory operations across the UK, Ireland and Malta, supporting new product registrations, line extensions, indications and post-approval activities while ensuring compliance with local regulatory and quality requirements.

Significant labelling experience is essential. You will collaborate with cross-functional teams, maintain regulatory tools and trackers, and liaise with