Schrödinger seeks an Associate Director of Regulatory Affairs to join our New York early clinical development team. This hire will report to the Director of Regulatory Affairs and will play an essential role in regulatory activities to support activities of global oncology trials in early clinical development.

The Schrödinger regulatory team supports drug development through early clinical proof of concept and is responsible for regulatory strategy and operations. Key deliverables include developing regulatory strategy components of integrated development plans; coordinating interactions with global health authorities to obtain scientific advice; global regulatory submissions (including IND and CTA submissions); safety reporting; and annual regulatory maintenance activities. 

Schrödinger applies a proprietary physics-based drug design and optimization platform to the drug discovery process, which expeditiously advances assets into the clinic - making this a dynamic and high-paced work environment.

The position:

We are seeking a highly motivated and experienced Associate Director Regulatory Affairs with expertise in hematology / oncology to join our Drug Discovery and Early Development team. The successful applicant will report to the Director of Regulatory Affairs.

A key competency of this hire will include a demonstrated ability to support global health authority submission for first-in-human oncology studies. The right candidate should be comfortable driving IND preparation, IMPD development; CTR compliant CTA applications (initial submissions and maintenance); managing health authority interactions (such as scientific advice meetings); orphan drug designation (ODD) submissions to the FDA and the EMA; and advising teams on asset strategy; indication strategy; clinical study designs and regulatory plans. Finally, having sufficient working knowledge of regulatory CMC within the EU to support globalization efforts.

Responsibilities:

  • Accountable for developing and implementing innovative global regulatory strategies to maximize the likelihood of regulatory success across multiple regions (US, EU, Asia-Pacific).
  • Integrates the European regulatory, legal, scientific/medical and business perspectives to achieve the optimal regulatory outcomes in accordance with company objectives.
  • Accountable for planning and executing submission strategy for major regulatory dossiers to the FDA and/or EMA.
  • Actively participates in regional organizational activities across projects.
  • Accountable for conducting regulatory risk planning and mitigation.
  • Provides information to support planning and maintenance of the regulatory budget.
  • Participates in key interactions with health authorities and communicates health authority feedback to drug discovery and clinical development teams.
  • Oversees development and maintenance of internal Global Regulatory Affairs practices and procedures.
  • Remains up to date on the global regulatory environment, regulations and guidance (in the NA and EU regions).
  • Maintains knowledge of the disease areas through regulatory intelligence and KOL interactions.
  • Participates in due diligence activities and alliance management for partnered programs.
  • Watches, anticipates and acts on trends and changes in the European and international regulatory environment which may have an impact on the business.
  • Develops and maintains strong functional relations with regulatory vendors across multiple regions.  

Essential Qualifications and Experience:

  • Bachelor's degree; Advanced degree preferred
  •  A minimum of 5 years in regulatory affairs leading strategy development and strategy implementation in a cross-functional project team setting across multiple regions (NA and EU) .
  • Expert understanding of policy, laws, regulations and guidelines as they apply to U.S. FDA  for drug development and approval. 
  • Understanding of EU regulatory principles and their impact on company's development and business goals
  • Regulatory experience and knowledge in multiple phases of drug development across various therapeutic areas.
  • Experience managing regulatory affairs in Hematology/Oncology is required.
  • Demonstrated experience in strategic planning, preparing and leading CTA and IND submissions. 
  • In-depth knowledge of current global regulations and guidance (eg, US, EU, ICH, etc) essential as they relate to the overall global regulatory strategy. Understanding of legal and business aspects related to EU regulatory procedures and outcomes
  • Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
  • Demonstrated ability to anticipate, analyze and resolve complex global regulatory-related problems and lead in situations of uncertainty.
  • Domestic and occasional international travel is required.
  • Outstanding presentation, data interpretation and communication skills.
  • Skilled at working in a multidisciplinary environment.

Desirable Skills:

  • Experience managing external teams at CROs including monitoring execution and timely delivery of results.
  • Dedicated team-player with in depth understanding of the complexities of cross functional management aspects
  • The successful candidate will be a self-starter who is proactive and results-oriented with high performance standards.
  • Comfortable working across a number of disease areas and able to shift gears quickly.
  • Must be open to change and the unknown with a creative and resourceful spirit.

 

Pay and perks:

Schrödinger understands it’s people that make a company great. Because of this, we’re prepared to offer a competitive salary, equity-based compensation, and a wide range of benefits that include healthcare (with dental and vision), a 401k, pre-tax commuter benefits, a flexible work schedule, and a parental leave program. We have catered meals in the office, a company culture that is relaxed but engaged, and over a month of paid vacation time.  Our Office Management team also plans a myriad of fun company-wide events. New York is home to our largest office, but we have teams all over the world. Schrödinger is honored to have been included in Crain's New York Best Places to Work, BuiltIn's NYC Best Place to Work, and Newsweek's list of America's 100 Most Loved Workplaces.

Estimated base salary range: $170,000 - $215,000. Actual compensation package is dependent on a number of factors, including, for example, experience, education, degrees held, market data, and business needs. If you have any questions regarding the compensation for this role, do not hesitate to reach out to a member of our Strategic Growth team.
 
Sound exciting? Apply today and join us!
 
As an equal opportunity employer, Schrödinger hires outstanding individuals into every position in the company. People who work with us have a high degree of engagement, a commitment to working effectively in teams, and a passion for the company's mission. We place the highest value on creating a safe environment where our employees can grow and contribute, and refuse to discriminate on the basis of race, color, religious belief, sex, age, disability, national origin, alienage or citizenship status, marital status, partnership status, caregiver status, sexual and reproductive health decisions, gender identity or expression, sexual orientation, or any other protected characteristic. To us, "diversity" isn't just a buzzword, but an important element of our core principles and key business practices. We believe that diverse companies innovate better and think more creatively than homogenous ones because they take into account a wide range of viewpoints. For us, greater diversity doesn't mean better headlines or public images - it means increased adaptability and profitability.

Apply for this Job

* Required
resume chosen  
(File types: pdf, doc, docx, txt, rtf)
cover_letter chosen  
(File types: pdf, doc, docx, txt, rtf)


Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Schrödinger’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.


Please reach out to our support team via our help center.
Please complete the reCAPTCHA above.