Working @ Immatics

Director, Regulatory Affairs

Permanent employee, Full-time · Houston (TX)

Overview
We are currently seeking a Full Time US DIRECTOR OF REGULATORY AFFAIRS to support our REGULATORY AFFFAIRS team under the direction of our Global Sr. Director, Regulatory Affairs. Ideally, this position will be located onsite in Houston, TX a few days per week at least. However, exceptions will be made for onsite work at least once per month if the ideal candidate lives remotely. 

The primary purpose of this position is to lead our US Regulatory Affairs team and to ensure compliance with regulatory requirements.
Your mission
The main responsibilities of this position will include but are not limited to the following tasks:
  • Leads Regulatory Operations in the US and develops and improves regulatory processes
  • Leads and develops the US Regulatory Affairs team
  • Develops regulatory strategies and implementation plans and feeds into cross functional project teams 
  • Ensures compliance with regulatory requirements and adhere to internal corporate policies and operating processes.
  • Provides timely and clear updates on project timelines, deliverables, and issues.
  • Works with multiple stakeholders in cross functional teams.
  • Ensures production of high-quality regulatory submission documents.
  • Develops and maintains regulatory document archiving and tracking databases.
  • Develops and maintains regulatory knowledge of regulations and guidelines.
  • Contributes in review and authoring of SOPs.
Your profile
The qualifications for this position include, but are not limited to the following:
  • REQUIRED: Bachelor’s Degree. Degree in Science is strongly preferred.
  • A minimum of ten (10) years of experience in Regulatory Affairs with 5 years of management experience.
  • Experience with biologicals and/or gene & cell therapy in oncological indications is a plus.
  • Strong knowledge of FDA regulations and GxP quality guidelines.
  • Experience with CTD and document management systems.
  • Experience with clinical trial registries.
  • Strong leadership and team building skills.
  • Strong coordination and problem solution abilities.
  • Manages issues proactively, manage conflicts, and mitigate regulatory risk.
  • Good organization and time management skills.
  • Strong oral and written communication skills.
Why us?
What Immatics Offers
We are a committed and inspired company and cherish the collegial, highly motivated and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking, and initiative. We believe in supporting our employees’ professional and social skills. In addition, we offer: 
  • Competitive Total Rewards package
    1. Base Salary 
    2. Annual Bonus 
  • Stock Options – based on position level 
  • 401K plan with company match 
  • Generous Holiday Time 
  • Generous Paid Time Off (PTO) for ALL EMPLOYEES regardless of position level
  • Full Benefits
    1. Health Insurance 
    2. Dental/Vision insurance  
    3. Short-Term and Long-Term Disability 
    4. Other voluntary insurance (Pet, Legal Shield Identity Theft Protection, Travel Assistant, Accidental Injury and Critical Illness,)
    5. Family Medical Leave
    6. Parental Leave 
    7. Employee Assistance Program
  • Life Insurance policy 
  • Additional Voluntary Life Insurance
  • Personal time with the CEO in your first 30 days 
  • Collaborative and family environment
  • Monthly Site meetings with fun team building events
  • Participation in the annual Houston BioChili Cookoff 
  • Themed Holiday party 
  • Social Community Outreach participation 
  • Development training and planning 
  • Various committees to foster collaboration and involvement within Immatics 
  • Hybrid work schedules (based on position need and supervisor’s approval)
 
Notice
Notice to Third-Party Recruiters/Staffing Agencies Recruitment is managed through Immatics US’ Human Resources department. Resumes will only be accepted from staffing agency/recruiters if there is a signed contract in place. Recruiters are requested to not contact our hiring managers or employees directly to inquire about open positions or to present candidates. In the event a staffing agency/third-party recruiter submits a resume without a contract in place, the candidate submitted will be considered unsolicited and treated as if the candidate submitted their resume directly to Immatics US, and no fee/payment will be paid. Recruiters interested in working with Immatics US can submit their information to HR-US@immatics.com, and we will contact you if needed. 
 
Immatics values diversity and inclusion. Immatics N.V. and all Immatics subsidiaries are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. 
About Us
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets.

This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.