Senior Director, Regulatory Affairs in Abbeyville, Colorado at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Regulatory Affairs based in the United States.

This is a senior regulatory leadership opportunity with responsibility for shaping global regulatory strategy across a pharmaceutical product portfolio.
The Senior Director will guide programs from early development through registration and post-approval lifecycle management.
Working closely with Clinical Development, Medical Affairs, commercial teams, and executive leadership, this role will influence critical development and regulatory decisions.
You will lead complex interactions with FDA, EMA, and other global health authorities while proactively managing regulatory risks and opportunities.
The position combines strategic leadership with hands-on oversight of major submissions, clinical regulatory planning, and regulatory intelligence.
You will also build and mentor a high-performing regulatory organization and help establish scalable submission and governance practices.
This role is ideal for an experienced regulatory professional who thrives in complex, high-impact environments and is motivated by advancing innovative therapies for patients.

• Develop and own global regulatory strategies for pipeline and marketed products spanning early development, registration, approval, and post-approval lifecycle management.
• Serve as the primary regulatory strategist on cross-functional development teams, aligning regulatory plans with clinical, medical, commercial, and organizational objectives.
• Provide proactive regulatory intelligence, risk assessments, strategic recommendations, and executive-level briefings to senior leadership and, when appropriate, the Board.
• Lead interactions with FDA, EMA, and other global health authorities, including Type A, B, and C meetings, Scientific Advice procedures, and Innovation Office engagements.
• Partner with Clinical Development on early-stage and registration-enabling trial strategies, providing regulatory guidance on endpoints, patient populations, statistical analysis plans, and labeling considerations.
• Review protocols, Investigator’s Brochures, Clinical Study Reports, and other clinical documentation to ensure consistency with regulatory strategy and applicable requirements.
• Lead IND and CTA submissions and amendments, including regulatory strategy and response planning for clinical holds.
• Direct BLA, NDA, and MAA submission planning and execution, including preparation and review of Module 2 summaries and coordination of cross-functional submission teams.
• Oversee major regulatory filings and post-approval submissions, including supplements, annual reports, and other applicable regulatory updates.
• Establish submission timelines, resource plans, governance processes, and readiness frameworks to ensure high-quality and timely filings.
• Partner with Regulatory Operations to maintain eCTD compliance, submission infrastructure, and appropriate regulatory documentation standards.
• Monitor evolving FDA, EMA, ICH, PDUFA, and international regulatory requirements and assess their potential impact on development and commercial programs.
• Build, mentor, develop, and retain a high-performing regulatory affairs team while fostering strong cross-functional collaboration and accountability.

• Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field; an advanced degree is preferred.
• 12+ years of regulatory affairs experience within the pharmaceutical, biotechnology, medical device, or related industry, or an equivalent combination of experience and education.
• Demonstrated success leading BLA, NDA, or MAA submissions from initial planning through regulatory approval.
• Deep knowledge of FDA regulations and guidance, including 21 CFR and ICH guidelines, with strong working knowledge of EMA and other major global regulatory frameworks.
• Proven experience leading Health Authority meetings and managing complex, high-stakes regulatory interactions.
• Strong clinical regulatory strategy expertise, including experience advising on protocol design, clinical trial strategy, endpoints, and agency negotiations.
• Demonstrated leadership experience managing, mentoring, and developing regulatory affairs professionals.
• Strong strategic thinking, risk assessment, communication, negotiation, and decision-making skills.
• Ability to influence senior stakeholders and effectively communicate complex regulatory considerations to technical and non-technical audiences.
• RAC certification through RAPS is a plus.
• Experience across multiple therapeutic areas or product modalities, including small molecules, biologics, gene therapies, or combination products, is desirable.
• Global regulatory experience involving ex-US submissions and health authority interactions is desirable.
• Experience with expedited regulatory pathways such as Breakthrough Therapy, Fast Track, Accelerated Approval, or similar designation programs is preferred.

• Anticipated annual base salary range of $259,000–$317,000, with final compensation based on experience, qualifications, training, and internal equity.
• Eligibility for an annual bonus target.
• Equity awards and equity incentive opportunities, subject to applicable eligibility requirements.
• 401(k) retirement plan with a generous employer match.
• Medical, prescription drug, dental, and vision coverage.
• Life insurance and disability benefits.
• 12 weeks of paid parental leave.
• Up to 12 weeks of living organ and bone marrow leave.
• Flexible time off.
• Annual winter holiday shutdown.
• At least 11 paid holidays per year.
• Opportunity to shape global regulatory strategy and influence the development and lifecycle management of innovative therapies.
• Senior-level exposure to executive leadership, global health authorities, and cross-functional development teams.