Regulatory Affairs Manager

3 weeks ago

Hertford, United Kingdom NEON HEALTHCARE LTD Full time

Job Title: Regulatory Affairs Officer

About the Role:

We are seeking a highly motivated Regulatory Affairs Officer to join our team at Neon Healthcare Ltd. As a key member of our Regulatory Affairs team, you will be responsible for supporting the post-approval activities for our product portfolio.

Main Responsibilities:

  • Maintain the life-cycle of all aspects of the registered particulars for our products.
  • Assist in the creation, collation, and publication of required documentation for the CTD dossier.
  • Implement and communicate changes to the Marketing Authorisation across stakeholder groups, ensuring all compliance activities are correctly managed.
  • Work closely with internal and external teams to develop and maintain packaging artwork, patient information leaflets, and other regulatory documentation.
  • Perform product information and CMC compliance activities throughout the 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 to ensure compliance and timely approvals.
  • Maintain regulatory files and databases in good order and track changes in documents submitted to agencies or partners.
  • Collaborate with the team to ensure compliance with company policies, procedures, and training expectations.
  • Perform other duties as necessary to support the team and company objectives.

Requirements:

  • A minimum of a Bachelor's degree in a relevant field, such as science, engineering, or medical/scientific writing.
  • Minimum 2 years of experience in Regulatory Affairs or a related field.
  • Experience preparing technical documentation for submission to regulatory agencies.
  • Excellent verbal and written communication skills.
  • Ability to work independently and manage day-to-day regulatory activities for a portfolio of products.
  • Able to multitask and manage conflicting priorities with sound time-management skills.
  • Able to identify compliance risks and escalate when necessary.

About Us: 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. We are committed to delivering high-quality products and services to our customers while adhering to the highest regulatory standards.

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