Assoc. Dir, Regulatory Affairs-CMC

Scorpion Therapeutics; North Wales (Montgomery County); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Annual bonus and long-term incentive

Medical/dental/vision

Retirement (401(k))

Paid holidays/vacation

Compassionate and sick days

Job summary

Scorpion Therapeutics seeks a senior candidate to lead AI-enabled regulatory CMC initiatives in a fast-paced biotech environment. You will drive AI drafting, digital tooling adoption, and cross-functional collaboration to modernize regulatory submissions.

You will mentor teams, manage change, and coordinate with R&D, Manufacturing, and Regulatory Operations to ensure seamless data handoffs and enterprise alignment. Travel up to 10% may be required.

Qualifications

• 5+ years in pharma/biotech with strong Regulatory CMC/Regulatory Affairs background.
• Hands-on experience building/optimizing regulated digital tools and modern AI/LLM solutions.
• Enterprise solution delivery experience improving business outcomes.
• Technical change management (repeatability assessments, job aids, end-user training).
• Mentoring/coaching on digital projects/workflows; strong matrix collaboration and communication; project coordination.
• Up to 10% travel.

Responsibilities

• Drive AI-enabled regulatory authoring capabilities (incl. Module 2/3) and develop job aids.
• Monitor emerging AI/digital technologies and assess utility for Regulatory CMC processes.
• Lead cross-functional work for AI authoring, process automation, regulatory intelligence, and digital transformation.
• Establish and embed a CMC digital/AI operating model aligning localized AI efforts with enterprise digital strategies.
• Coordinate with Regulatory CMC Systems/Operations on digital solutions affecting regulatory platforms (e.g., Veeva).
• Serve as primary point of contact for key digital tools/platforms (e.g., ERA App) and support CMC digital tracking/reporting.
• Partner with R&D and Manufacturing to identify shared digital opportunities and ensure data/process handoffs.
• Champion enterprise AI adoption via networks and change management/training.
• Propose/lead/mentor digital project teams, including GRACS CMC summer intern projects.

Skills

Change management

Collaboration

eCTD

Emerging technologies

Regulatory CMC

Documentation strategy

Project leadership

Regulatory submissions

Stakeholder partnerships

Regulatory compliance

Education

BS or equivalent in scientific/technical/regulatory field

Tools

Veeva

ERA App

Job description

Responsibilities

• Drive AI-enabled regulatory authoring capabilities (incl. Module 2/3), develop job aids, and identify generative AI drafting opportunities.
• Monitor emerging AI/digital technologies and assess utility for Regulatory CMC processes.
• Lead cross-functional work for AI authoring, process automation, regulatory intelligence, and digital transformation.
• Establish and embed a CMC digital/AI operating model aligning localized AI efforts with enterprise digital strategies.
• Coordinate with Regulatory CMC Systems/Operations on digital solutions affecting regulatory platforms (e.g., Veeva).
• Serve as primary point of contact for key digital tools/platforms (e.g., ERA App) and support CMC digital tracking/reporting.
• Partner with R&D and Manufacturing to identify shared digital opportunities and ensure data/process handoffs.
• Champion enterprise AI adoption via networks (e.g., AI Pioneers Champions Network), feedback loops, and change management/training.
• Propose/lead/mentor digital project teams, including GRACS CMC summer intern projects.

Education

• Minimum BS or equivalent in a Scientific/Technical/Regulatory field (chemistry, biology, pharmacy, computer science, or data analytics preferred).

Required Experience

• 5+ years in pharma/biotech with strong Regulatory CMC/Regulatory Affairs background.
• Hands-on experience building/optimizing regulated digital tools and modern AI/LLM solutions.
• Enterprise solution delivery experience improving business outcomes.
• Technical change management (repeatability assessments, job aids, end-user training).
• Mentoring/coaching on digital projects/workflows; strong matrix collaboration and communication; project coordination.
• Up to 10% travel.

Required Skills

• Change management, collaboration, eCTD, emerging technologies, stakeholder partnerships, regulatory CMC/compliance/documents/strategy/submissions/reporting, project leadership, regulatory documents.

Benefits

• Annual bonus and long-term incentive (if applicable); medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.