Global Regulatory Strategy Director, Clinical Programs

Ascendis Pharma A/S; Palo Alto (CA); Hybrid; USD 215,000 - 240,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, dental, and vision plans

Life and AD&D insurance

Disability benefits

Pet Insurance

Job summary

Ascendis Pharma is seeking an experienced Director, Regulatory Affairs Clinical Strategy in Palo Alto, CA to lead global regulatory plans across clinical, non-clinical, and CMC disciplines. You will guide submissions, mentor team members, and partner with cross-functional programs in a fast-growing biopharma environment.

The role requires a minimum of 10 years in regulatory affairs, strong leadership, and an ability to translate complex regulations into practical action.

Qualifications

• Minimum of 10 years regulatory experience across clinical, non-clinical and CMC areas.
• Experience leading cross-functional teams on submissions.
• Strong knowledge of ICH and global/regional regulatory requirements.

Responsibilities

• Develop and implement global regulatory strategies for clinical, non-clinical and CMC disciplines.
• Lead preparation of submissions and coordinate with international teams.
• Mentor regulatory professionals and guide project teams on regulatory topics.
• Maintain up-to-date knowledge of regulatory requirements and communicate changes.

Skills

Regulatory strategy

Cross-functional leadership

Global submissions

ICH/regulatory knowledge

Regulatory affairs leadership

Education

Bachelor's Degree

Job description

Ascendis Pharma is seeking an experienced Director, Regulatory Affairs Clinical Strategy in Palo Alto, CA to lead global regulatory plans across clinical, non-clinical, and CMC disciplines. You will guide submissions, mentor team members, and partner with cross-functional programs in a fast-growing biopharma environment.

The role requires a minimum of 10 years in regulatory affairs, strong leadership, and an ability to translate complex regulations into practical action.