Director, Regulatory Affairs

Latigo Creative

. Report to the Vice President of Regulatory .

Posted 9/16/2026full-timeThousand Oaks • California • United StatesLead💰 $230,000 - $270,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in regulatory strategy execution and implementation, with a strong focus on FDA interactions, IND submissions, and compliance with global health authority requirements. Possesses a quality mindset in regulatory submissions and project management across clinical development and commercialization planning.

Highest-signal resume keywords

Regulatory Strategy ExecutionFDA Interaction ManagementIND Submission ExperienceRegulatory Project ManagementAttention to Detail

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission PreparationClinical Development InputRegulatory Risk MitigationStudy Protocol GuidanceStatistical Analysis Plan SupportCMC Submission QualityRegulatory Document ReviewRegulatory Compliance KnowledgeEU CTA/MAA FamiliaritySmall Molecule Experience

Soft Skills

Excellent Written CommunicationExcellent Verbal CommunicationStrong Analytical SkillsProblem-Solving Skills

Industry Keywords

FDAEMAMHRAINDCTANDARegulatory AffairsLife SciencesClinical TrialsCommercialization Planning

About the role

Key responsibilities & impact

Report to the Vice President of Regulatory
Lead execution and implementation of regulatory strategies supporting product development
Support regulatory interactions with FDA, EMA, MHRA, and other global health authorities
Provide regulatory input into clinical development plans, study designs, and labeling strategies
Anticipate and mitigate regulatory risks and develop contingency plans
Oversee preparation, review, and submission of INDs, CTAs, NDAs, briefing documents, and other regulatory documents
Ensure regulatory submissions are timely, complete, and accurate
Maintain knowledge of applicable regulatory requirements and ensure organizational compliance
Lead or support regulatory meeting requests and briefing documents for FDA Type B/C meetings and equivalent ex-US interactions
Partner with Clinical Development, CMC, Nonclinical, Quality, and leadership teams
Provide regulatory guidance on study protocols, statistical analysis plans, and clinical trial conduct
Apply a quality mindset to CMC submissions and inspections

Requirements

What you’ll need

Bachelor’s, Master’s, PharmD, or PhD, preferably in life sciences
Minimum of 8 years of Regulatory experience
Direct experience leading/supporting FDA interactions
Ability to oversee regulatory activities and manage processes from research/discovery, CMC, and clinical through commercialization planning
US registration experience ideal
Experience with small molecules and pain (or similar area) preferred
Experience with IND submission and maintenance
Knowledge of US procedures
Familiarity with EU CTA/MAA regulatory processes preferred
Regulatory Project Management experience preferred
Excellent written and verbal communication skills
Strong analytical and problem-solving skills
Attention to detail

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Latigo Creative Website LinkedIn All Job Openings 1 - 10 employees Founded 2017 📣 Marketing 📱 Media 🤝 B2B Marketing
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B2B Latigo Creative is a design and branding company that develops visual identities and cohesive brand experiences for businesses. They provide graphic and packaging design, logo/identity creation, print and event collateral, signage and POS, art direction, 3D product visualization and photography, web design and WordPress development, video and motion graphics, and social media and digital strategy. Latigo emphasizes collaboration with agency partners and stakeholders to deliver consistent, effective creative across physical and digital channels. Director, Regulatory Affairs Job not on LinkedIn 🔥 1 hour ago 🏢🏡 Thousand Oaks – Hybrid 💵 $230k - $270k / year ⏰ Full Time 🔴 Lead 🚔 Compliance 👻 Ghost score 0% Apply Now Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Report to the Vice President of Regulatory
Lead execution and implementation of regulatory strategies supporting product development
Support regulatory interactions with FDA, EMA, MHRA, and other global health authorities
Provide regulatory input into clinical development plans, study designs, and labeling strategies
Anticipate and mitigate regulatory risks and develop contingency plans
Oversee preparation, review, and submission of INDs, CTAs, NDAs, briefing documents, and other regulatory documents
Ensure regulatory submissions are timely, complete, and accurate
Maintain knowledge of applicable regulatory requirements and ensure organizational compliance
Lead or support regulatory meeting requests and briefing documents for FDA Type B/C meetings and equivalent ex-US interactions
Partner with Clinical Development, CMC, Nonclinical, Quality, and leadership teams
Provide regulatory guidance on study protocols, statistical analysis plans, and clinical trial conduct
Apply a quality mindset to CMC submissions and inspections 🎯 Requirements
Bachelor’s, Master’s, PharmD, or PhD, preferably in life sciences
Minimum of 8 years of Regulatory experience
Direct experience leading/supporting FDA interactions
Ability to oversee regulatory activities and manage processes from research/discovery, CMC, and clinical through commercialization planning
US registration experience ideal
Experience with small molecules and pain (or similar area) preferred
Experience with IND submission and maintenance
Knowledge of US procedures
Familiarity with EU CTA/MAA regulatory processes preferred
Regulatory Project Management experience preferred
Excellent written and verbal communication skills
Strong analytical and problem-solving skills
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