Senior Director, Global Regulatory Affairs

Role Overview & Key Functions:

The Global Regulatory & CMC Lead is responsible for the development and implementation of regulatory strategies for specific projects, while serving as the regulatory representative on the respective program teams. This includes Karyopharm’s key clinical programs, international submissions in collaboration with our multiple alliance partners, and all CMC initiatives and submissions.

Reporting to our Senior Vice President, Regulatory Affairs, you will positively impact patients’ lives with the following contributions:

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  Accountable for the assigned regulatory portfolio from strategy development and implementation to execution of submissions for all stages of developmen
• tOversee clinical trial submissions and regulatory strategies globall
• yProvide regulatory leadership and guidance to assigned program teams and CMC project team
• sResponsible for regulatory compliance with pre- and post-approval filings and reporting requirement
• sDevelop response and submission strategies to regulatory information requests in close collaboration with cross-functional team members and alliance partners, as applicabl
• eDevelop various briefing packages and regulatory applications to the FDA and other global health authorities, as applicable, including CMC project
• sLead as Regulatory CMC in all Change Control assessments and implementation of global roll-out including all external partner
• sSupport Regulatory inspections, as neede
• dContribute to regulatory intelligence, regulatory science, and regulatory polic
• yWork collaboratively within Regulatory Affairs and cross-functional team
• sPrepare and deliver effective presentations for external and internal audience
• sContact regulatory agencies relevant to assigned projects or programs, as appropriat
• eParticipate and contribute to Health Authority meeting

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Candidate Profile & Requirement

• s:Minimum B.S. degree in life/health/technical sciences requir
• edPostgraduate degree in Regulatory Affairs a pl
• usPrevious oncology experience highly preferr
• edMinimum 10+ years of regulatory experience within the biotech or pharmaceutical indust
• ryA minimum of 7 years regulatory experience within the drug development and approval process in IND/CTAs/Marketing Applications; and a minimum of at least 5 years of Regulatory CMC hands-on experien