Regulatory Affairs Specialist for Pharmaceutical Product Compliance

6 days ago


Watford, Hertfordshire, United Kingdom NEON HEALTHCARE LTD Full time

Job Overview

NEON HEALTHCARE LTD seeks a highly skilled Regulatory Affairs Specialist to support the post-approval activities for its product portfolio.

About NEON HEALTHCARE LTD

We are an ambitious and fast-growing pharmaceutical company that develops, produces, markets, and sells prescription-only medicines to hospitals, wholesalers, and retail pharmacies. With significant operations in the UK, we aim to expand our activities into other international markets.

Responsibilities

The successful candidate will:

  • 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, 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.
  • 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.
  • Provide Regulatory Affairs support during internal and external audits.
  • Assist in the development of standard processes for Regulatory Affairs processes and systems.

Requirements

The ideal candidate should possess:

  • A minimum of a Bachelor's degree, preferably in science, engineering, medical/scientific writing, or public health administration.
  • 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.
  • 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.

Estimated Salary: £45,000 - £60,000 per annum



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