Global Regulatory & Operations Lead
Our client is a global supplier of sterile injectable pharmaceutical products, with a portfolio of drugs for regulated and semi-regulated markets worldwide. The company's research and development organization has a robust pipeline of products in development.
Responsibilities
* Understand HPRA BoH requirements for hosting a market authorization.
* Act as a Responsible Person for a Market Authorization 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.
* For MAs, directly manage: 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.