Expiry Date: 28-09-2019
Category Regulatory Affairs
Salary: On Application
Job Type: Full Time
Regulatory Affairs EU Project Mgr – Strategic RA development role for a Global Biotech – Brussels
Location: Belgium, Brussels
Take responsibility for a number of key projects in a high level strategic role which will include closely liaising (and learning from) a locally based Global Regulatory Leader for development strategies, leading/submitting Clinical Trial Applications, PiPs, Scientific Advice (and briefing packages) and full MAA ownership/leadership (or line extensions/Type II variations) for an expanding biotech company that has shown great levels of growth in the last 3 years and has over 30 indications in its development pipeline.
As the EMEA Regulatory Project Manager you will play a pivotal role in providing support to the GRL with respect to leading your projects or all types of submissions and strategic initiatives. You will be responsible for leading strategic decisions on development projects through the Centralized procedure MA (as the agency liaison) as this department continues to take the lead for a number high profile successful filings.
Working from the Global HQ you will have lots of opportunities for professional progression which includes people management and direct team leadership or becoming a global regulatory leader for the EU and US for Biotechnology development projects and registrations.
The salary for this position is excellent with a performance related bonus of approx. 10% and extensive benefits with high level healthcare and pension package and a blue-chip relocation package which includes removals, storage and unpacking of items, a settling in-allowance/sign-on fee and company apartment for 3 months (or longer if needed).
The holder of this position will take responsibility for a number of key projects for which they will co-ordinate all EMEA regulatory activities whilst liaising with a locally based GRL. For development projects, this would include providing input into the Global Regulatory Liaison for development strategies, leading/submitting Clinical Trial Applications, PiPs, Scientific Advice (and briefing packages) and full MAA ownership/leadership (or line extensions/Type II variations). For maintenance activities, this would include the compilation of regulatory strategies, coordinating any submissions via collaboration with local Regulatory contacts, liaising with Commercial and mentoring/supporting junior team members. This client has almost 30 indications currently in their development pipeline so your projects will be mostly around PII and PIII to MA.
Excellent training and development opportunities are available, but it essential for you to have some experience of working on regulatory development projects.
To apply for this role, please press the red “Apply for position” button, or contact Theo Moore or Matt Greig TODAY on +44 (0)207 801 3380 for an initial discussion about the role and other projects.
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