Global Regulatory & Operations Lead - Operations Lead - Ireland/Dublin
Our client is a global supplier of sterile injectable pharmaceutical products, with a diverse portfolio of sterile injectable drugs. Their state-of-the-art research and development organization boasts a robust pipeline of innovative products in development, poised for entry into regulated and semi-regulated markets worldwide.
Responsibilities
* The ability to comprehend HPRA BoH requirements for hosting a market authorisation is essential.
* Serving as a Responsible Person for a Market Authorisation filing.
* Effective management and engagement with Global Regulatory colleagues and stakeholders.
* Communication and coordination with vendors/service providers, ensuring aligned activities and timelines.
* Development of a quality system to manage the MA filing, meeting HPRA requirements.
* Capability to support a WDA for the release of product into Europe.
* Regulatory Affairs experience in dossier creation and submission in Europe.
* Representation of the company as the lead person with all relevant local authorities.
* Management of Regulatory Affairs activities associated with changes to MAs for all products registered in territories under responsibility.
* Direct management of MA-related tasks: Creation, maintenance, and management of current registered details.
* Establishment and coordination of relationships with product CMOs and wholesale distributors.
Your Experience
* 8-10 years of professional experience in Regulatory Affairs within the Pharmaceutical industry.
* Experience working with the HPRA.
* Reviewing regulatory dossiers.
* Excellent communication and stakeholder management skills.
* Experience collaborating with global teams and Regulatory Authorities.
This role requires a strong background in Regulatory Affairs and excellent communication skills.