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Regulatory Affairs Specialist
1 month ago
Neon Healthcare is seeking a highly skilled Regulatory Affairs Officer to support the Regulatory team with post-approval activities for the product portfolio.
Main Responsibilities:
- Maintain all aspects of the MAs registered particulars.
- Assist with the creation, collation, and publication of required documentation for the CTD dossier.
- Implement and communicate MA changes across stakeholder groups, ensuring 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, ensuring 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.
- Communicate with other departments, clients, and regulatory authorities.
- Maintain regulatory files/database and chronologies in good order, tracking changes in documents submitted to agencies or partners.
- Work collaboratively across the organisation, ensuring compliance with company policies, procedures, and training expectations.
Requirements:
- A minimum of a Bachelor's degree is required, with a concentration in science, engineering, medical/scientific writing, or public health administration 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, take responsibility for managing day-to-day regulatory activities for a portfolio of products, and work effectively within the Regulatory Affairs team and with other stakeholders.
