Global Regulatory & Operations Lead - Operations Lead - Ireland/Dublin
Our client is a global supplier of sterile injectable pharmaceutical products, with a robust pipeline of products in development that will be brought to regulated and semi-regulated markets worldwide. Their portfolio includes dosage forms in multidose vials, multiple presentations within the blow-fill-seal offering, and small molecule cytotoxic products.
Responsibilities:
* Understanding 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 to align 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 their responsibility.
* Creating, maintaining, and managing MA current registered details.
* Building relationships and coordinating 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.