Global Regulatory & Operations Lead
Our client is a global supplier of sterile injectable pharmaceutical products. They market and distribute a portfolio of sterile injectable drugs. Their state-of-the-art research and development organization has a robust pipeline of products in development that they will bring to regulated and semi-regulated markets around the world.
Responsibilities:
* Understand HPRA BoH requirements for hosting a market authorisation.
* Act as a Responsible Person for a Market Authorisation filing.
* Manage and engage with Global Regulatory colleagues and stakeholders.
* Communicate and coordinate vendors/service providers - aligning activities and timelines.
* Build a quality system to manage the MA filing that meets HPRA requirements.
* Support a WDA for release of product into Europe.
* Regulatory Affairs experience in dossier creation and submission in Europe.
* Represent the company as the lead person with all relevant local authorities.
* Manage Regulatory Affairs activities associated with changes to MAs for all products registered in the territories under their responsibility.
* Manage MAs, directly: Creation, maintenance, and management of MA current registered details.
* Build relationships and coordinate with product CMOs and wholesale distributors.
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 and Regulatory Authorities.