Our client, a world-leading pharmaceutical company has a unique opportunity for a Regulatory Affairs Manager for the EU region.
This position will allow you to work on both the strategic development and post-market maintenance of biologic products. This role is not specific to a therapeutic area, you will have the option to choose what area you would like to focus on.
The company is very well respected in the industry, and this position will allow you to master a variety of skills across the product lifecycle, allowing you to choose the ideal path of progression
-Assist Development teams and Regulatory management in developing strategies that are EU-appropriate and take advantage of EU regulatory systems and processes
-Provide leadership on both late and early-stage clinical development related process and strategy to ensure timely study conduct end to end.
-Provide support on MAA related process and strategy to ensure timely product approvals with competitively differentiated labelling.
-Manage the preparation and submission of technically complex regulatory submissions, with supervision, for assigned products in line with regional regulatory requirements
-Participate in and sometimes lead local and/or EU company process improvement initiatives
The ideal candidate
-3+ years within Regulatory Affairs
-Knowledge and experience working with the EMA
-Experience with leading Regulatory submissions. For example CTA, variation, orphan, renewals, and PIP applications
-MAA submissions is a bonus
If this sounds like a position that could be of interest to you or you would like to hear more information, then please get in contact and arrange a call.