Expiry Date: 27-11-2022
Categories Biotech, Regulatory Affairs
Job Type: Full Time
Our client is a top ten Biotech with one of the best Oncology pipelines in the industry and this is a great opportunity to work in an established regulatory team where creativity and autonomy is encouraged.
Location: Based in New Jersey, US.
We have a number of new roles open for motivated and experienced Regulatory Affairs professionals to operate as both US Regulatory liaisons and/or GRLs, initially for early-stage development assets in Oncology, but with the intention that you lead (strategic) activities as the indications move through the pipeline to BLA/NDA/MAA and global registrations. We have positions graded Snr Manager and Associate Director, and both roles come with excellent overall packages.
My client is a Global Biotechnology company developing medicines across a number of modalities include Cell Therapies for a number of different types of Oncology including Hemo and Immuno-Oncology and probably have the best Oncology pipeline currently in the industry today. Many of the senior regulatory Oncology team members here are highly accomplished and enjoy mentoring and supporting the AD’s and Snr managers around strategic input, leadership and Health authority meetings, interactions, and responses.
As the Regional and/or Global Regulatory Lead your role will grow in challenges and responsibilities and move from early development to late development/registration (US & EU). You will lead your own programs in a highly collaborative environment where your ability to build strong relationships with internal and external partners is key. You will need to be an adaptable and strategic thinker with the ability to generate creative solutions to complex problems and identify different and novel ways to find answers.
Ideally you will have some knowledge in supporting interactions with health authorities, including US FDA, and be familiar in key regulatory pathways for product development, for example pediatric plans, orphan drugs, Regulatory Agency advice, expedited development (e.g. Fast Track, Breakthrough Designation, PRIME). Therapeutic experience in Oncology is desirable but not essential.
In return, you will be working with accomplished team leaders, receiving mentoring and support at all times, with access to one of the best Oncology pipelines in the industry. Salary and packages are exceptional, and my client also likes to promote those who have shown they are creative regulatory leaders and liaisons.
If you are interested in a role where you will be encouraged to take the lead and make an impact through collaborating and driving development, then call me Theo Moore or Roland Schnapka today on US 908 348 6714 or US 587 216 9302 or email us via CV@AdvTalent.com and we will immediately respond to your application with more information on this role.
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