Global Regulatory & Operations Lead
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. These include dosage forms in multidose vials, multiple presentations within the blow-fill-seal offering, and small molecule cytotoxic products.
Responsibilities
* The need for an understanding of HPRA BoH requirements for hosting a market authorisation.
* Act as a Responsible Person for a Market Authorisation filing.
* Manage & engage with Global Regulatory colleagues & stakeholders.
* Communicate & coordinate vendors/service providers - aligning activities & timelines.
* Bauild a quality system to manage the MA filing that meets HPRA requirements.
* Capable of supporting 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 the relevant local authorities.
* Manage Regulatory Affairs activities associated with changes to MAs for all products registered in the territories under his/her responsibility.
* For MAs, directly manage: Creation, maintenance and management of MAs current registered details.
* Bauild relationships & coordinate with product CMO's & wholesale distributor.
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.