Regulatory Affairs Specialist

1 week ago

Watford, Hertfordshire, United Kingdom NEON HEALTHCARE LTD Full time
Regulatory Affairs Compliance Officer

Background

Neon Healthcare is a dynamic and fast-growing pharmaceutical company that develops, produces, markets, and sells prescription-only medicines to hospitals, wholesalers, and retail pharmacies. Founded by entrepreneurs with a successful track record in building pharmaceutical businesses, the company has significant operations in the UK and is looking to expand its activities into other international markets.

Job Summary

This role supports the Regulatory team with post-approval activities for the product portfolio. The successful candidate will work closely with the Senior Regulatory Affairs Officer to ensure all compliance activities are correctly managed.

Key Responsibilities

  • Implementation and communication of MA changes across stakeholder groups
  • Ensure all compliance activities are correctly managed
  • Work closely with in-house, 3rd party designers and contract sites for packaging artwork development and updates
  • Generation and maintenance of 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
  • Developing and maintaining a sound knowledge of European and UK regulatory legislation and guidelines to provide advice and expertise internally for matters related to our products
  • Communicating with other departments, clients, and regulatory authorities
  • Maintain regulatory files/database and chronologies in good order. Ensure compliance with company policies, procedures, and training expectations
  • Provide support during New Product Development and Lifecycle Management projects
  • Prepare responses to regulatory agencies' questions and other correspondence to resolve post-submission queries ensuring timely approvals
  • Provide Regulatory Affairs support during internal and external audits
  • Assists in the development of standard processes for Regulatory Affairs processes and systems

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
  • Work on own initiative and take responsibility for managing the day-to-day regulatory activities for a portfolio of products
  • Work effectively within the Regulatory Affairs team and with other stakeholders to deliver on Company Objectives and Goals
  • Able to demonstrate a genuine interest and knowledge of the regulatory environment and a desire to succeed in a regulatory affairs role in the pharmaceutical industry
  • Ability to identify compliance risks and escalate when necessary

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