We are currently seeking a
OR MANAGER for our REGULATORY AFFAIRS DEPARTMENT to support our team. This position will work in Houston, Texas. Your analytical reasoning and action-oriented style as well as your organization and communication skills will contribute to the team’s success.
This position will provide regulatory and quality support for assigned clinical research. The responsibilities may include preparation of FDA meeting requests, meeting packages, preparation of responses to FDA questions, management, preparation and submission of initial IND applications and IND amendments to the US FDA. It will also provide strategic regulatory guidance and information to projects; acquire pertinent regulatory information from agencies and organizations; support regulatory agency interactions, communications, and submissions; and review project regulatory documentation to ensure compliance with applicable regulatory regulations and guidelines.
(all genders welcome)
The main responsibilities of this position will include but are not limited to the following tasks:
- Develop regulatory strategies and implementation plans.
- Ensure compliance with regulatory requirements and adhere to internal corporate policies and operating processes.
- Provide timely and clear updates on project timelines, deliverables, and issues.
- Work with multiple stakeholders and support multiple projects.
- Ensure production of high-quality regulatory submission documents.
- Maintain regulatory document archiving and tracking databases.
- Maintain regulatory knowledge of regulations and guidelines.
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 Five (5) years of experience in Regulatory Affairs. Industry experience preferred.
- Ability to coordinate tasks and effectively work with multiple stakeholders.
- Good organization and time management skills.
- Manage issues proactively, manage conflicts, and mitigate regulatory risk.
- Experience with CTD and document management systems.
- Experience with clinical trial registries.
- Strong knowledge of FDA regulations and GxP quality guidelines.
- Strong oral and written communication skills.
We expect a high degree of independent working, analytical reasoning and excellent communication skills. You embrace rapidly changing requirements with an open mind, think outside the box and show a high degree of flexibility in an environment which is marked by a constant striving for excellence. You approach tasks in a structured,
reliable and foresighted manner, combined with an elevated level of individual responsibility, enthusiasm and strong social skills.
What We Offer
We are a committed and inspired team 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: We enable them to join conferences and trainings as well as to enjoy our Immatics benefits – e.g. job bike, job ticket, Health Programs, childcare benefits, relocation allowance, Company summer and winter events.
We are a committed and inspired team 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. Immatics offers partial subsidized health, dental and vision insurance, 401(k), 160 hours of PTO annually, paid holidays, paid parking, paid short/long term disability/AD&D and life insurance.
If you’re interested in working for Immatics, please forward your CV along with a letter of introduction via e-mail to RecruitingUS@immatics.com. For more detailed information about Immatics and privacy protection visit www.immatics.com.
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@imamtics.com, and we will contact you if needed