Regulatory Affairs Specialist

4 weeks ago

Hertford, United Kingdom NEON HEALTHCARE LTD Full time

About this role

Neon Healthcare Ltd is an ambitious and fast-growing pharmaceutical company that develops, produces, markets, and sells prescription-only medicines to hospitals, wholesalers, and retail pharmacies. Reporting to the Senior Regulatory Affairs Officer, this role supports the Regulatory team with post-approval activities for the product portfolio.

Key Responsibilities

• Maintain all aspects of registered particulars for the product portfolio. This includes life-cycle maintenance of the MAs.

• Assist with the creation, collation, and publication of all required documentation for the CTD dossier.

• Implement and communicate MA changes across stakeholder groups, ensuring all compliance activities are correctly managed.

• Work closely with in-house, 3rd-party designers and contract sites for packaging artwork development and updates.

• Generate and maintain patient information leaflets and packaging components, including artwork management, and ensure regulatory compliance with legislation and company approval systems.

• Perform product information and CMC compliance activities for the entire product life cycle.

• Develop and maintain a sound knowledge of European and UK regulatory legislation and guidelines to provide advice and expertise internally for matters related to our products.

• Communicate with other departments, clients, and regulatory authorities.

• Maintain regulatory files/database and chronologies in good order. Maintain a system for tracking changes in documents submitted to agencies or partners.

Requirements

• A minimum of a Bachelor's degree is required. A concentration in science, engineering, medical/scientific writing, public health administration is preferred.

• Minimum 2 years of working experience within Regulatory Affairs or equivalent.

• Experience preparing technical documentation for submission to regulatory agencies.

• Excellent verbal and written communication and interactive skills.

• Ability to work on own initiative and take responsibility for managing day-to-day regulatory activities for a portfolio of products.

• Ability to work effectively within the Regulatory Affairs team and with other stakeholders to deliver on company objectives and goals.

• Ability to multitask and manage conflicting priorities with sound time-management skills.

• Ability to identify compliance risks and escalate when necessary.

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