Associate Director, Regulatory Submission Management

Scorpion Therapeutics; California (MO); On-site; USD 182,000 - 236,000; Full time

Benefits offered by this job

Discretionary bonus

Stock-based long-term incentives

Paid time off

Medical/dental/vision/life insurance

Job summary

Scorpion Therapeutics is seeking an Associate Director, Regulatory Submission Management to lead the planning and execution of highly complex global submissions, partnering with RA Liaisons and GRAD to align filing plans and timelines.

The role requires extensive experience in regulatory affairs, ability to guide cross-functional teams, and strong project management skills, with travel as needed.

Qualifications

• 10+ years with BS/BA or 8+ years with MS/MA or MBA.
• Experience managing submission teams and regulatory projects.
• Knowledge of US/EU drug/biologics development and regional requirements.
• PMP or PM certification (plus); Agile knowledge (plus).
• Advanced submission management tools such as Veeva, Docubridge, Smartsheet, Planisware, MS Project.

Responsibilities

• Direct planning and execution of regulatory programs/submission activities.
• Create global filing plans and maintain program timelines.
• Lead/coordinate submission communications and team meetings.
• Organize high-quality documents for stakeholders; act as subject area expert.
• Ensure submissions comply with global health authority requirements and ICH/local/regional requirements.

Skills

Regulatory submission management

Cross-functional leadership

Project management

Negotiation / conflict resolution

Education

BS/BA

MS/MA

MBA

PharmD/PhD

Tools

Veeva

Docubridge

Smartsheet

Planisware

MS Project

Job description

Associate Director, Regulatory Submission Management (RSM)

Responsibilities

• Direct planning and execution of regulatory programs/submission activities for highly complex global submissions and initiatives.
• Partner with RA Liaisons and GRAD to create global filing plans and maintain program-level timelines with regulatory milestones.
• May lead regulatory portfolio planning as needed.
• Lead/coordinate moderately complex project communications; plan and conduct submission team meetings; anticipate obstacles and develop solutions.
• Facilitate cross-functional communication across Regulatory Affairs (e.g., Labeling, Advertising/Promotion, Innovation, IDEP, Medical Writing, Regulatory CMC) and other functional partners.
• Support RSM across programs/projects; attend sub-team meetings; organize ad hoc working groups.
• Initiate/contribute to local and global process improvements.
• Manage 2–4 major submissions (e.g., NDA, MAA, BLA, sNDAs/T2Vs, IND, RtQs).
• Coordinate/track submission project information (minutes, timelines, action items, deliverables) and ensure integration of timing, scope, and resources.
• Organize/lead high-quality documents for internal/external stakeholders; act as subject area expert.
• Ensure submissions comply with global health authority requirements and ICH/local/regional requirements and company policies.

Qualifications

• Basic: 10+ years with BS/BA OR 8+ years with MS/MA or MBA.

Preferred

• 10+ years relevant submission management/regulatory project management/operations experience (biopharma); or 8+ years with MA/MS/MBA; or 5+ years with PharmD/PhD.
• Proven ability managing submission teams; strong negotiation/conflict resolution; track record managing multiple submissions.
• Knowledge of drugs/biologics development and regional requirements (e.g., US/EU); functional/therapeutic area expertise.
• Mentorship/leading in matrixed environments; PMP or other PM certification (plus); Agile knowledge (plus).
• Advanced submission management tools/reporting skills (e.g., Veeva, Docubridge, Smartsheet, Planisware, MS Project).
• Ability to travel as needed.

People Leader Accountabilities

• Create inclusion; develop talent; empower teams.

Compensation/Benefits (if stated)

• $182,070.00–$235,620.00 base salary; may be eligible for discretionary bonus, stock-based long-term incentives, paid time off, and company-sponsored medical/dental/vision/life.