Senior Director Regulatory CMC Gene Therapy Regulatory Connect
are working with a very highly regarded Biotech with a huge
development pipe-line of early and late stage products in the Gene
therapy space. They are looking for a Head of Regulatory CMC
(Senior Director) to lead a product platform team that is
responsible for delivering all Regulatory CMC objectives for Gene
Great opportunity for someone looking to transition from CMC
Biologics to Gene Therapy. Previous Gene Therapy experience is not
needed but Biologics is a must.
Leads and manages a team of FTEs, contract staff and vendors to
execute the regulatory activities.
Represents Regulatory CMC on platform/project discussions at
internal meetings as well as at meetings with regulatory agencies
for all CMC related issues.
Provides CMC regulatory guidance for global development and
registration programs to junior team members and peers across the
Manages the dossier development process for CMC modules for
IND/IMPD/CTA and BLA/NDA/MAA submissions and prepares and review
submission-ready CMC and marketing registration applications,
supplements, amendments and variations.
Manages and ensures compliance with all reporting requirements,
including annual and periodic reports.
Assesses and communicates CMC regulatory requirements to ensure
all development activities are in compliance with applicable
regulations and guidelines.
M.S. required, Ph.D. preferred, in a biomedical discipline with
at least 12 years of regulatory experience supporting both
development projects and marketed products (or 7+ years Ph.D.).
Prior hands on experience of FDA CMC regulatory submissions is
essential with strong knowledge and experience in CMC product
Experience in preparing INDs, IMPDs, NDA and/or MAA
submission(s) and prior experience in agency engagements and
interactions is essential.
Established knowledge of US and international regulatory CMC
guidelines and regulations; strong knowledge of eCTD elements and
structure and regulatory writing skills.
US Office – We Work 980 6th Ave Bromley, New York NY 10018