Job Title: Regulatory Affairs Officer
Description:
At Neon Healthcare Ltd, we are seeking a highly skilled Regulatory Affairs Officer to join our team. As a key member of our Regulatory Affairs team, you will be responsible for supporting post-approval activities for our product portfolio.
Main Duties and Responsibilities:
* Life-cycle maintenance of all aspects of the MAs registered particulars.
* Assist with the creation, collation and publication of all required documentation for the CTD dossier.
* Implementation and communication of 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.
* 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. Maintain system for tracking changes in documents submitted to agencies or partners.
* Work collaboratively across organisation.
* Ensure compliance with company policies, procedures and training expectations.
* Perform other appropriate duties, where necessary.
* Provide support during New Product Development and Lifecycle Management projects.
* Define, gather and assemble information needed for submissions according to applicable regulations and relevant guidelines.
* Lead and/or support the submission of licenses and authorisations for new products and changes to existing products.
* 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 process 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
* Excellent verbal and written communication and interactive skills.
* 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 multitask and manage conflicting priorities with sound time-management skills.
* 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
Work with us:
We are an ambitious and fast-growing pharmaceutical company that develops, produces, markets, and sells prescription only medicines to hospitals, wholesalers, and retail pharmacies. If you are passionate about Regulatory Affairs and want to be part of a dynamic team, please apply for this exciting opportunity.