Organizational Overview:

Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.

The Role:

This highly dynamic team is seeking an entrepreneurial and strategic (Associate) Director, Regulatory Affairs to play a key role on our cross-functional R&D team. In this role, you will have the opportunity to lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. The individual in this position will have the unique opportunity to shape the Regulatory function of a rapid-growth biotechp.

Key Responsibilities:

  • Lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. Ensure global regulatory requirements and strategy are understood by project teams
  • Play a hands-on role in planning, preparing, and coordinating regulatory documents for submission to global health authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries
  • Close collaboration with internal and external cross-functional team members to ensure achievement of submissions and timely approvals of applications
  • Lead interactions with FDA and other Health Authorities
  • Communicate project updates and risks to senior management and stakeholders across the organization. Track regulatory commitments, deliverables, and overall project timelines
  • Maintain up-to-date knowledge and understanding of global regulatory requirements.
  • Initiate and contribute to the development of policies and procedures in alignment with GxPs, global regulatory requirements and guidance, and corporate objectives
  • Provide hands-on leadership to cross-functional teams in planning, preparing, and coordinating documents for submission to global authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries
  • Lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks
  • Communicate project updates and risks to senior management and stakeholders across the organization. Track regulatory commitments and deliverables. Interact efficiently and independently with consultants
  • Provide hands-on leadership to cross-functional teams in planning, preparing, and coordinating documents for submission to global authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries
  • Lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks
  • Communicate project updates and risks to senior management and stakeholders across the organization. Track regulatory commitments and deliverables. Interact efficiently and independently with consultants

Requirements:

  • 10-12 years of biopharmaceutical experience, which includes at least 8-10 years of direct experience in Regulatory Affairs 
  • Advanced degree (Master’s or PhD) in a relevant scientific discipline is preferred
  • Experience in biologics drug development, parenteral products, including combination products, orphan/rare disease product development
  • Experience in developing and implementing regulatory strategies in a global environment.
  • Comprehensive understanding of applicable global regulations, guidance, and practices
  • Demonstrated hands-on experience in the preparation and submission of global regulatory documents including clinical trial applications and maintenance (IND/CTA), NDA/BLA/MAA, briefing documents, and agency queries
  • Prior experience leading interactions with FDA and other global regulatory authorities
  • Strategic and analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
  • Works collaboratively and efficiently with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, and external vendors and contract organizations
  • Strong team and project management skills
  • Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to diverse internal and external audiences including executive leadership
  • Ability to thrive in a collaborative and fast-paced environment
  • Results-oriented individuals with a strong work ethic and ability to complete projects with minimal oversight
  • Knowledge of GxP, ICH, FDA, EMA and other global regulations and guidances
  • Attention-to-detail and an ability to balance analytical and critical-thinking skills to develop data-driven, strategically oriented regulatory proposals and documents
  • Experience developing regulatory strategies for biologics and/or rare disease development programs
  • Commitment to company values and culture
  • Proven ability to adapt to change and uncertainty as projects evolve
  • Strong oral and written communicator
  • Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks
  • Ability to multi-task and adjust priorities quickly while working under tight deadlines.
  • Skilled in developing collaborative internal and external relationships
  • Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Project)

Work Environment:

  • Immunovant's headquarters is located in New York City, The position is flexible for remote work.
  • Dynamic, interactive, fast-paced, and entrepreneurial environment
  • Domestic or international travel are required (10-20%)

Apply for this Job

* Required
  
  


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 IMVT Corporation’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.


Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, 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?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

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.