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Associate Director Regulatory Submission Jobs (NOW HIRING)

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Associate Director Regulatory Submission information

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$47K

$137.6K

$185.5K

How much do associate director regulatory submission jobs pay per year?

As of Sep 12, 2026, the average yearly pay for associate director regulatory submission in the United States is $137,563.00, according to ZipRecruiter salary data. Most workers in this role earn between $110,000.00 and $174,000.00 per year, depending on experience, location, and employer.

What are popular job titles related to Associate Director Regulatory Submission jobs?

For Associate Director Regulatory Submission jobs, the most frequently searched job titles are:

Associate Director, Regulatory Submission Management

California, MO โ€ข On-site

Scorpion Therapeutics
51 - 200 employees

$182K - $235K/yr

Other

Medical, Dental, Vision, Life, PTO

Posted 4 days ago


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 2โ€“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)
  • $182,070.00โ€“$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.
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