Senior Manager Regulatory Affairs

Job title:

Senior Manager Regulatory Affairs

Company

Lifelancer

Job description

Job Title: Senior Manager Regulatory AffairsJob Location: Stafford, TX 77477, USAJob Location Type: RemoteJob Contract Type: Full-timeJob Seniority Level: Mid-Senior levelFLSA Classification : Exempt/SalarySchedule: Monday – Friday; 8:00 am to 5:00 pmDepartment: Regulatory Affairs – USReports to: US Senior Director Regulatory AffairsSupervisory responsibilities: NoLocation: Fully Remote or On-site at 13203 Murphy Rd. Suite 100, Stafford, TX 77477Position Summary/objective:Immatics is a clinical-stage 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 detail-oriented 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 cross-functional 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 cross-functional team environment
• Must be resourceful and self-motivated, 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 one-on-one, 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 key-pad, 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 yearRequired 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 E-Verify 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, medical​conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or ​expression, veteran status, or any other status protected under federal, state, or local law.”Other duties: Please 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.Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.For more details and to find similar roles, please check out the below Lifelancer link.

Expected salary

Location

Stafford, Staffordshire

Job date

Thu, 23 Jan 2025 23:09:19 GMT

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