Director, Global Regulatory Affairs, Clinical Strategy

Ascendis Pharma

. Develop and implement global regulatory strategies covering clinical, non-clinical, and CMC disciplines .

Posted 9/22/2026full-timePalo Alto • California • United StatesLead💰 $215,000 - $240,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive regulatory expertise with a focus on developing and implementing global regulatory strategies, managing complex submissions, and leading cross-functional teams. Proficient in navigating ICH and regional regulatory requirements while mentoring regulatory professionals.

Highest-signal resume keywords

Regulatory Strategy DevelopmentSubmission PreparationCross-Functional Team LeadershipRegulatory Requirements KnowledgeRisk Mitigation Strategies

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsRegulatory Dossiers FilingComplex Document ReviewDrug-Device Combination ProductsInternational Regulatory Affairs

Soft Skills

MentoringInfluencingCollaborationCommunication

Certifications & Qualifications

Bachelor's Degree

Industry Keywords

ICH RequirementsClinical Regulatory AffairsCMC RegulationsGlobal Labeling DocumentsInvestigational ProductsMarketed ProductsCTAsIMPDsINDsBLAs

About the role

Key responsibilities & impact

Develop and implement global regulatory strategies covering clinical, non-clinical, and CMC disciplines
Ensure timely preparation of organized and scientifically valid submissions
Translate regulatory requirements into practical plans for project teams with international participants
Provide strategic and operational regulatory input for cross-functional CMC, non-clinical, and clinical areas
Collaborate with CMC regulatory team members and other project team members
Contribute to global clinical and regulatory plans and strategies
Identify and propose risk mitigation strategies
Influence project teams and subteams across international site locations
Contribute to global labeling documents, including prescribing information and patient information
Prepare and/or manage technically complex submissions
Interact extensively with departments outside Regulatory Affairs
Maintain current knowledge of complex regulatory requirements
Communicate regulatory information changes to project teams
Schedule and arrange own activities and those of direct reports
Mentor and potentially supervise regulatory professionals
Work under the direction of a Senior Regulatory Affairs professional

Requirements

What you’ll need

Minimum of 10 years overall regulatory experience, preferably including experience managing investigational and marketed products
Bachelors Degree required
Prior experience representing Regulatory Affairs on cross-functional teams desirable
Must be capable of effectively leading teams in preparation of submissions
Experience working on international teams desirable
Extensive knowledge of regulatory requirements, including ICH and regional requirements
Understanding of current global and regional trends in regulatory affairs and ability to assess their business impact
Must be capable of critically reviewing complex technical documents and influencing colleagues across functions
Experience with drug-device combination products preferred, but not required
Ability to travel up to 10-20% domestically and internationally
Experience filing regulatory dossiers including CTAs, IMPDs, and INDs required
Experience with BLAs, NDAs, and MAAs a plus

Benefits

Comp & perks

401(k) plan with company match
Medical, dental, and vision plans
Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
Company-provided short and long-term disability benefits
Pet Insurance and Legal Insurance
Employee Assistance Program
Employee Discounts
Professional Development
Health Saving Account (HSA)
Flexible Spending Accounts
Various incentive compensation plans
Accident, Critical Illness, and Hospital Indemnity Insurance
Mental Health resources
Paid leave benefits for new parents
Discretionary annual bonus or incentive compensation plan eligibility
Discretionary stock-based long-term incentives
Paid time off
Comprehensive benefits package
Hybrid workplace arrangement