Director, Global Regulatory Affairs Clinical Strategy

About the role

Ascendis Pharma, a fast-growing global biopharmaceutical company focused on rare diseases in endocrinology and oncology, is hiring a Director, Regulatory Affairs Clinical Strategy. The role develops and implements global regulatory strategies covering clinical, non-clinical and CMC disciplines, ensures timely, scientifically valid submissions, and translates regulatory requirements into practical plans for international project teams. It is based in Palo Alto, CA.

Key responsibilities

• Provide strategic and operational regulatory input for cross-functional (CMC, non-clinical and clinical) areas with project team members, including CMC regulatory team members.
• Help develop global clinical and regulatory plans and strategies, propose risk mitigation strategies, and influence project teams across international sites.
• Contribute to global labeling documents such as prescribing information and patient information.
• Prepare and manage complex submissions requiring extensive interaction with departments outside regulatory affairs.
• Maintain up-to-date knowledge of complex regulatory requirements and communicate changes to project teams.
• Schedule and arrange own activities and those of direct reports, working under the direction of a Senior Regulatory Affairs professional.

Required profile

• Minimum of 10 years of overall regulatory experience, preferably including managing investigational and marketed products.
• Bachelor's degree required.
• Experience representing Regulatory Affairs on cross-functional teams and leading teams in submission preparation is desirable; experience on international teams is desirable.
• Ability to travel up to 10-20% of the time domestically and internationally.
• Experience filing regulatory dossiers including CTAs, IMPDs and INDs required; experience with BLAs/NDAs/MAAs is a plus.

Required skills

• Extensive knowledge of regulatory requirements, including ICH and regional requirements, and awareness of global and regional trends.
• Ability to critically review complex technical documents and influence colleagues across functions.

What we offer

• Estimated salary range of $215-240K DOE, depending on experience, qualifications and location.
• Possible discretionary annual bonus, incentive compensation plan, stock-based long-term incentives and paid time off.
• 401(k) with company match, medical, dental and vision plans, life and AD&D insurance, disability benefits, pet and legal insurance, employee assistance program, health savings account and flexible spending accounts.