Senior Principal Scientist, Regulatory Liaison

Ladders; United States; Remote; USD 191.000 - 300.000; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision coverage

401(k) retirement plan

Paid holidays and vacation

Compassionate and sick leave

Zusammenfassung

Ladders is seeking a Senior Principal Scientist, Regulatory Liaison for a remote US-based role. You will shape global regulatory strategy across development programs, guiding products from planning through approval and lifecycle management.

You will collaborate with Product Development, Global Regulatory, and cross-functional teams to align registration requirements and submission plans. Responsibilities include leading the Global Regulatory Team, preparing regulatory interactions, and

Qualifikationen

• 10+ years in drug development, primarily in regulatory; or 7+ years with MD/PhD/PharmD, including 5 years in regulatory.
• Strong strategic thinking and problem-solving skills.
• Effective communicator with the ability to influence and negotiate across functions.
• Experience with direct interactions with major Health Authorities, including FDA and EMA.
• Demonstrated expertise in global regulatory strategies.

Aufgaben

• Develop worldwide regulatory strategies to optimize product labeling and approval timelines.
• Act as the global point of contact for regulatory strategy and registration requirements.
• Provide expert regulatory advice to Product Development Teams throughout the product life cycle.
• Lead the Global Regulatory Team in coordinating cross-functional regulatory support.
• Prepare and submit regulatory applications and manage communications with agencies.
• Review and approve local registration study protocols for secondary markets.
• Lead cross-functional efforts for FDA advisory committee preparations.

Kenntnisse

Regulatory strategy

Cross-functional collaboration

Regulatory communications

FDA/EMA interactions

Ausbildung

B.S./M.S. in a relevant field

M.D./PhD/PharmD in a relevant field

Jobbeschreibung

For our client, we are seeking a Senior Principal Scientist, Regulatory Liaison to join the team of a leader in the Pharmaceuticals & Biotech space.

In this remote role, you will shape global regulatory strategy for a portfolio of development programs, helping guide products from early planning through approval and lifecycle management. You will serve as a key connector across Product Development, Global Regulatory, and other cross-functional teams to align registration requirements, labeling objectives, and submission plans. This position will also play an important role in preparing regulatory interactions, supporting agency communications, and contributing to major milestone readiness across the development process.

Location: Remote - US based candidates only, no visa sponsorship available

Compensation: $190,800 – $300,300 annually

Responsibilities

• Develop worldwide regulatory strategies to optimize product labeling and approval timelines.
• Act as the global point of contact for regulatory strategy and registration requirements.
• Provide expert regulatory advice to Product Development Teams throughout the product life cycle.
• Lead the Global Regulatory Team in coordinating cross-functional regulatory support.
• Prepare and submit regulatory applications and manage communications with agencies.
• Review and approve local registration study protocols for secondary markets.
• Lead cross-functional efforts for FDA advisory committee preparations.

Qualifications

• B.S. or M.S. with 10+ years in drug development, primarily in regulatory; or M.D., PhD, or PharmD with 7+ years, including 5 years in regulatory.
• Strong strategic thinking and problem-solving skills.
• Effective communicator with the ability to influence and negotiate across functions.
• Experience with direct interactions with major Health Authorities, including FDA and EMA.
• Demonstrated expertise in global regulatory strategies.

Benefits

• Comprehensive medical, dental, and vision healthcare for employees and families.
• Retirement benefits including 401(k).
• Paid holidays and vacation days.
• Compassionate and sick leave days.

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.