Senior Advisor, Regulatory Starting Material

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the identification, justification, and regulatory strategy for Regulatory Starting Materials across synthetic routes for drug substances.

• Coordinate resupply campaigns for starting materials and scale-up initiatives, which include inventory management, production forecasts, manufacturing schedules, suite reservations, and contracting.

• Draft and review CMC regulatory submission materials, encompassing Module 3 sections, briefing documents, and agency communications for INDs, NDAs, and MAAs.

• Organize and facilitate interactions with health authorities, including Type C meetings and scientific advisory procedures.

• Collaborate with Process Chemistry and Analytical Development to assess synthetic routes, evaluate structural relevance, impurity fate-and-purge, and conduct risk assessments.

• Establish and document the non-GMP/GMP manufacturing boundary for drug substance processes.

• Lead technology transfer and process modifications that impact RSM designation in preparation for commercial manufacturing.

• Manage relationships with drug substance/API CMOs and RSM suppliers, ensuring technical oversight, conducting site visits, supplier qualification, and dual sourcing.

• Keep abreast of global regulatory guidance and agency precedents, updating internal strategies, templates, and risk assessments accordingly.

• Work alongside Regulatory Affairs, Quality, Supply Chain, and Manufacturing to coordinate timelines, submission readiness, and ensure supply continuity.

• Assist with due diligence processes involving drug substance manufacturing routes and associated risks of starting materials.

• Offer subject matter expertise during regulatory inspections and audits.

• Build, lead, and mentor a team that supports RSM and drug substance CMC strategy initiatives.

⛳️ Requirements

• An advanced degree in chemistry, chemical engineering, or a related discipline; a PhD is highly preferred.

• A minimum of 7 years of relevant experience in CMC, process chemistry, or drug substance/API development and manufacturing, including leadership roles in starting material or CMC regulatory strategy programs.

• Experience in supporting late-stage clinical and/or commercial drug substance programs.

• Comprehensive knowledge of ICH Q11 and relevant regional guidelines regarding the selection and justification of Regulatory Starting Materials.

• Proven experience in authoring and defending CMC regulatory submissions, including interactions with health authorities concerning starting materials or drug substance manufacturing strategies.

• Strong expertise in synthetic/process chemistry, route scouting, impurity control strategies, and structural relevance arguments.

• Experience in managing drug substance/API CMOs and raw material suppliers, including batch record reviews and manufacturing oversight.

• Familiarity with cGMP requirements and the distinctions between GMP and non-GMP operations.

• Preferred experience in facilitating technology transfer from clinical to commercial scale.

• Excellent leadership, cross-functional collaboration, and scientific writing/communication abilities.

• Capable of identifying and mitigating risks related to starting materials that could impact regulatory timelines, supply, or overall program success.

• Willingness to travel domestically and internationally, estimated at 10–20%.

🏝️ Benefits

• Company bonus based partly on both individual and company performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Comprehensive medical, dental, vision, and prescription drug benefits.

• Flexible benefits options, including healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits, encompassing employee assistance programs, fitness benefits, and activities through employee clubs.

• Employee resource groups available to all staff.