Regulatory Affairs Professional Opportunity
The role of Regulatory Affairs Manager is critical to the success of our pharmaceutical company. As a key member of our regulatory team, you will be responsible for leading and executing operational registration and life-cycle management projects for our products.
You will promote high-quality regulatory best practices, develop strategies, and improve processes to ensure efficient communication and timely delivery of registrations. Your responsibilities will also include line management of junior team members and effective planning, management, and delivery of project workloads.
Key Responsibilities:
* Plan, manage, and deliver assigned project workloads
* Prepare and submit regulatory documents, including Marketing Authorization Transfer, CMC variation filings, initial MAA filings, labeling updates, renewals, and publishing
* Communicate effectively with Regulatory Authorities and internal departments (CMC, Quality, PV, Legal, Supply Chain, Commercial, Medical, Clinical, QA) and local offices
* Manage external partners as needed
Qualifications & Experience:
We are seeking an experienced professional with a Pharmacy or Scientific primary degree and/or advanced degrees. You should have more than 5 years of human pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and emerging markets. Additionally, you should have experience with EU DCP and MRP MAAs, writing and preparing relevant CTD documents, and project management experience.
Requirements:
* Pharmacy or Scientific primary degree and/or advanced degrees
* >5 years human pharmaceutical regulatory experience
* Experience with EU DCP and MRP MAAs
* Project management experience
About the Opportunity:
This is a full-time/hybrid position that offers a challenging and rewarding career opportunity in a global pharmaceutical company. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.