Our client is a global supplier of sterile injectable pharmaceutical products. They currently market and distribute a portfolio of sterile injectable drugs. Our state-of-the-art research and development organization has a robust pipeline of products in development that we will bring to regulated and semi-regulated markets around the world.
Key Responsibilities
* The understanding of HPRA BoH requirements for hosting a market authorisation.
* Acting as a Responsible Person for a Market Authorisation filing.
* Managing and engaging with Global Regulatory colleagues and stakeholders.
* Communicating and coordinating vendors/service providers - aligning activities and timelines.
* Building a quality system to manage the MA filing that meets HPRA requirements.
* Supporting a WDA for release of product into Europe.
* Regulatory Affairs experience in dossier creation and submission in Europe.
* Representing the company as the lead person with all relevant local authorities.
* Managing Regulatory Affairs activities associated with changes to MAs for all products registered in the territories under responsibility.
* For MAs, directly managing: Creation, maintenance, and management of MA current registered details.
Your Experience
* 8-10 years of professional Regulatory Affairs experience in the Pharmaceutical industry.
* Experience working with the HPRA.
* Experience reviewing regulatory dossiers.
* Excellent communication and stakeholder management skills.
* Experience working with global teams & Regulatory Authorities.