Global Regulatory & Operations Lead - Operations Lead - Ireland/Dublin
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
1. The need for an understanding of HPRA BoH requirements for hosting a market authorisation.
2. Act as a Responsible Person for a Market Authorisation filing.
3. Manage & engage with Global Regulatory colleagues & stakeholders.
4. Communicate & coordinate vendors/service providers - aligning activities & timelines.
5. Build a quality system to manage the MA filing that meets HPRA requirements.
6. Capable of supporting a WDA for release of product into Europe.
7. Regulatory Affairs experience in dossier creation and submission in Europe.
8. Represent the company as the lead person with all the relevant local authorities.
9. Manage Regulatory Affairs activities associated with changes to MAs for all products registered in the territories under his/her responsibility.
10. For MAs, directly manage: Creation, maintenance and management of MAs current registered details.
11. Build relationships & coordinate with product CMO's & wholesale distributor.
Your Experience
1. 8-10 years of professional Regulatory Affairs experience in the Pharmaceutical industry.
2. Experience working with the HPRA.
3. Experience reviewing regulatory dossiers.
4. Excellent communication and stakeholder management skills.
5. Experience working with global teams & Regulatory Authorities.
If this role is of interest to you, please apply now
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