Full-Time

Associate Director of Regulatory Affairs

Updated on 4/25/2024

Schrödinger

Schrödinger

501-1,000 employees

Develops chemical simulation software for research


Compensation Overview

$170,000 - $215,000Annually

+ Equity-based compensation

Senior, Expert

New York, NY, USA

Required Skills
Communications
Requirements
  • Bachelor's degree; advanced degree preferred
  • Minimum of ten years in regulatory affairs leading strategy development and strategy implementation in a cross-functional project team setting across multiple regions
  • Expert understanding of policy, laws, regulations, and guidelines as they apply to the US FDA for drug development and approval
  • Understanding of EU regulatory principles and their impact on the company's development and business goals
  • Experience managing regulatory affairs in hematology/oncology
  • Demonstrated experience in strategic planning, preparing, and leading CTA and IND submissions
  • In-depth knowledge of current global regulations and guidance as they relate to the overall global regulatory strategy
  • Excellent organizational, writing, and time management skills to manage multiple ongoing projects simultaneously
  • Demonstrated ability to anticipate, analyze and resolve complex global regulatory-related problems and lead in situations of uncertainty
  • Willingness to travel
  • Outstanding presentation, data interpretation and communication skills
Responsibilities
  • Develop and implement innovative global regulatory strategies
  • Plan and execute submission strategy for major regulatory dossiers
  • Integrate European regulatory, legal, scientific/medical, and business perspectives
  • Conduct regulatory risk planning and mitigation
  • Provide information to support planning and maintenance of the regulatory budget
  • Participate in key interactions with health authorities
  • Oversee development and maintenance of internal global regulatory affairs practices and procedures
  • Remain up to date on the global regulatory environment
  • Maintain knowledge of disease areas through regulatory intelligence and KOL interactions
  • Participate in due diligence activities and alliance management
  • Watch, anticipate, and act on trends and changes in the international regulatory environment
  • Develop and maintain strong functional relations with regulatory vendors

Schrödinger develops advanced chemical simulation software for pharmaceutical, biotechnology, and materials research, utilizing a physics-based computational platform that integrates physics, chemistry, and predictive modeling to expedite innovation in drug discovery and materials design.

Company Stage

Grant

Total Funding

$652.2M

Headquarters

New York, New York

Founded

1990

Growth & Insights
Headcount

6 month growth

2%

1 year growth

9%

2 year growth

28%