Associate Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1998

About the Role

Ascendis Pharma is seeking an experienced Associate Director, Regulatory Affairs Clinical Strategy to join our dynamic team. This role is an exciting opportunity to contribute to a rapidly growing, innovative biopharmaceutical company focused on developing best-in-class therapeutics for rare diseases. The position will be based in Palo Alto, CA.

Responsibilities

• Develop and implement global regulatory strategies encompassing clinical, non-clinical, and CMC disciplines.
• Ensure timely preparation of organized and scientifically valid submissions.
• Translate regulatory requirements into practical, workable plans for project teams with international participants.
• Mentor and potentially supervise other regulatory professionals working on project teams and regulatory process-related topics.
• Provide strategic and operational regulatory input for cross-functional areas (CMC, non-clinical, and clinical) in collaboration with project team members.
• Contribute to the development of global clinical and regulatory plans, identify and propose risk mitigation strategies, and influence project teams across international site locations.
• Contribute to the development of global labeling documents (prescribing information and patient information).
• Prepare and/or manage technically complex submissions requiring extensive interaction with departments outside of 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.

Requirements

• Minimum of 8 years overall regulatory experience, preferably including experience managing investigational and marketed products.
• Bachelor’s Degree required.
• Prior experience representing Regulatory Affairs on cross-functional teams is desirable; must be capable of effectively leading teams in submission preparation.
• Experience working on international teams is desirable.
• Extensive knowledge of regulatory requirements, including ICH and regional requirements, and understanding of current global and regional trends in regulatory affairs.
• Ability to critically review complex technical documents and influence 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, INDs required; experience with BLAs/NDAs/MAAs a plus.

Qualifications

The ideal candidate will have a strong background in regulatory affairs, with a proven track record of managing complex submissions and cross-functional collaboration. Experience in rare diseases and drug-device combination products is highly desirable.

Skills

• Strategic thinking and planning.
• Strong communication and influencing skills.
• Ability to work independently and in a team environment.
• Attention to detail and organizational skills.
• Knowledge of global regulatory requirements and trends.

Pay

The estimated salary range for this position is $185,000 - $205,000 DOE. Actual salary determination is dependent on a variety of factors, including experience, qualifications, and geographic location.

Benefits

• 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 Savings Account (HSA) and Flexible Spending Accounts.
• Various incentive compensation plans.
• Accident, Critical Illness, and Hospital Indemnity Insurance.
• Mental Health resources.
• Paid leave benefits for new parents.

Ascendis Pharma is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees.