Associate Director, Regulatory Affairs
Legend Biotech US · Jersey EN
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In brief
Legend Biotech US is hiring: Associate Director, Regulatory Affairs in Jersey.
Duties
- Responsible to independently develop innovative, robust global regulatory strategies and ensure their efficient and effective execution for Legend…
- Lead the team efforts required for the submission of INDs, CTAs, and BLAs as well as related supplements/variations; ensure timely and high-quality…
- Lead the effort to evaluate the need to develop in-vitro diagnostic test or companion diagnostic tests for pipeline programs as needed.
- Oversee the maintenance of INDs, CTAs and BLAs, and ex-U.S. filings as required.
- Interface with the FDA and other health authorities to seek feedback and alignment on pre-clinical and clinical development strategies.
Excerpt from the ad
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy…
Source: ad by Legend Biotech US, published on Careers pages (ATS). MakeYouFirst summarises this ad; the advertiser remains responsible for its content.
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