Lead - Regulatory Affairs CMC

August 3

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Description

• Manage all aspects of CMC regulatory strategy development for Orca Bio products (early- to late-stage/registration/post-market). • Lead authoring of meeting package information for regulatory CMC interactions in the US and globally. • Oversee content development and authoring of Mod 3 and lead authoring of Mod 2.3 for BLA/MAA filings. • Lead teams in examining regulatory strategy options, provide relevant regulatory guidance. • Identify and assess regulatory risks and critical-path activities associated with CMC development programs and work to identify regulatory strategies to mitigate risks. • Monitor and analyze regulatory agency activities regarding CMC development and assess potential impact on the Orca Bio development programs and understand the regulatory landscape. • Evaluate proposed manufacturing changes for global impact and provide strategic regulatory strategies that support compliant change implementation. • Serve as CMC Regulatory Lead on cross functional project teams to achieve project milestones/goals. • Serve as the Regulatory point of contact for Contract Manufacturing Organizations and Qualified Persons. • Lead CMC regulatory submission development - Responsible for planning, coordinating, developing and authoring high quality, compliant and timely CMC (Quality) regulatory submissions according to current regulatory requirements and guidance to obtain efficient and timely regulatory approvals (IND/IMPD, BLA/MAA, pre-meeting briefing documents, etc.).

Requirements

• Bachelor’s degree (or equivalent) in life sciences, masters or advanced degree with strong scientific acumen; PhD preferred. • Prior regulatory filing (BLA) experience with cell or gene therapies preferred. • 10+ years working within the biotech/pharmaceutical industry, preferably at a small company. • 8+ years of pharma and/or biotech regulatory CMC-experience. • In-depth Knowledge of cGMP, CMC regulatory requirements, domestic and globally. • Ability to lead matrixed teams, drive and influence effective collaborations, with a hands-on mindset. • Strong scientific writing and oral communication skills with ability to summarize clearly and succinctly and tailor messaging to target audience. • Initiative-taking, self-disciplined, and able to function independently as well as part of a team, with a practical and flexible mindset. • Proficient in various computer applications such as MS Project, Office suite, Smartsheet, etc.