Senior Manager Regulatory Affairs
Senior Manager Regulatory Affairs
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Job Description
Job Title: Senior Manager Regulatory Affairs
Job Location: Stafford TX 77477 USA
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
FLSA Classification : Exempt/Salary
Schedule: Monday – Friday; 8:00 am to 5:00 pm
Department: Regulatory Affairs US
Reports to: US Senior Director Regulatory Affairs
Supervisory responsibilities: No
Location: Fully Remote or Onsite at 13203 Murphy Rd. Suite 100 Stafford TX 77477
Position Summary/objective:
Immatics is a clinicalstage biopharmaceutical company developing novel immunotherapies against cancer. We combine 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. Our goal is to provide cancer patients with innovative and effective treatments.
We are seeking a highly motivated and detailoriented Senior Manager Regulatory Affairs to join our US Team. The successful candidate will support Regulatory Project Leads in both Clinical and CMC aspects of drug development. The ideal candidate will have direct experience within a regulatory function and a desire to grow into a strategist role. Experience with cell and gene therapies or biologics in the oncology therapeutic area is a plus.
Essential functions:
- Take responsibility for routine submission content (e.g. 1572 updates 1572 waiver requests) and distribution of waiver granted letters for TMF filing
- Assist Regulatory Project Leads with tracking regulatory commitments deliverables submissions reviews and overall project timelines
- Support Regulatory Project Leads with ensuring content and quality of regulatory documentation including QC checks of submission packages
- Collaborate closely with crossfunctional team members to achieve timely submissions and approval/clearance of amendments.
- Review and provide feedback on packages to enable clinical study startup and assist in responding to clinical site queries
- Support with responses to FDA Requests for Information as needed
- Support annual document updates (DSUR IB Orphan Drug Annual Report)
- Support Regulatory Project Leads in gathering regulatory precedent information from approved products
- Provides initial submission and periodic updates regarding clinical studies to clinicaltrials.gov
Secondary functions:
- Review authoring and editing of SOPs that include Regulatory Affairs responsibilities as assigned
- Supports regulatory document archiving and tracking databases
Competencies:
- Demonstrated capacity of applying Regulatory Affairs Clinical CMC Quality and Nonclinical information to support overall product development
- Demonstrated ability to work in a crossfunctional team environment
- Must be resourceful and selfmotivated with excellent time management skills
- Strong communication skills (both written and oral)
- Take responsibility and ownership for assigned actions
- Adapt to changes in the work environment and demonstrate flexibility
- Uphold Immatics core values and behaviors
- Direct experience in a Regulatory Affairs function is required
Work environment:
This position is remote and should be performed in an office setting that simulates the work office environment. This office must be set up in a way that allows for privacy and quiet during work hours as well as a comfortable chair and desk. This position uses phone computer office equipment and supplies on a regular basis. Noise levels should be at a level which would allow for proper communication with other members virtually.
Physical demands:
- Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately loudly or quickly.
- Hearing – the ability to hear understand and distinguish speech and/or other sounds oneonone group or conference telephone and other sounds.
- Keyboarding – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard 10 keypad touch screens and others.
- Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects reading small print including the use of computers).
- Sitting – remaining in a sitting position for at least 50% of the time.
Travel required: Some travel is required may require travelling domestically a few times per year or internationally once per year
Required education and experience:
- Bachelor’s degree in life science field or;
- Minimum of 5 years of experience in Regulatory affairs for the pharmaceutical industry;
- Strong knowledge of US regulations and GxP guidelines
Preferred education and experience:
- Advanced degree in life science field or MBA;
- Experience with biologics and/or cell and gene therapy in oncological indications is a plus
Work authorization/security clearance requirements:
Legal eligibility to work in the United States is required. Immatics participates in EVerify and all new employees will be subject to the Department of Homeland Security requirements for employment.
Affirmative Action/EEO statement:
Immatics is an equal opportunity employer. All employment decisions including the decision to hire promote discipline or discharge will be based on merit competence performance and business needs. We do not discriminate on the basis of race color religion national origin ethnicity marital status age physical or mental disability medicalconditions pregnancy genetic information gender sexual orientation gender identity or expression veteran status or any other status protected under federal state or local law.”
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her duties: Pl
ease note this job description is not designed to cover or contain a comprehensive listing of activities duties or responsibilities that are required of the employee for this job. Duties responsibilities and activities may change at any time with or without notice. This job description may not cover all duties that take place on a daily basis and may be changed as business needs change. Employee will be responsible for adapting and learning the duties as described above or as the new ones are introduced.
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Employment Type
Full Time
