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Mid-Level Manager, Regulatory Affairs
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Qualifications, skills, and all relevant experience needed for this role can be found in the full description below. 1 day ago Be among the first 25 applicants Join to apply for the
Mid-Level Manager, Regulatory Affairs
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Jobright.ai Get AI-powered advice on this job and more exclusive features. Jobright is an AI-powered career platform that helps job seekers discover the top opportunities in the US. We are NOT a staffing agency. Jobright does not hire directly for these positions. We connect you with verified openings from employers you can trust. Job Summary: Baylor College of Medicine is seeking a Regulatory Affairs Manager to provide analytical, regulatory, and supervisory support for the clinical research team at The Center for Cell and Gene Therapy. The role involves training regulatory staff, developing regulatory strategies, and ensuring compliance with federal regulations and institutional policies. Responsibilities: • Maintain timely knowledge of federal regulations, institutional policies and ICH GCP guidelines in order to properly guide regulatory staff and investigators in preparing projects that are in compliance with those documents. • Responsible for confirming the content of regulatory submissions. • Work with the regulatory staff and investigators in developing protocol documents and consent forms as necessary, works with regulatory staff and investigators to assist in responding to queries from institutional review committees and other regulatory agencies including the FDA. As necessary submits and maintains such documents. • Assist and prepare for FDA meetings, inspections, and audits from regulatory agencies. • Help to maintain systems meant to optimize communication of changes in regulatory processes to investigators, regulatory staff, and other involved parties. • Help to maintain systems meant to optimize protocol specific information distribution to investigators, research staff, and other health care providers. • Assist in submission and maintenance of regulatory documents as needed to ensure that all clinical research projects remain open and are conducted in compliance with all regulations and policies (federal and local). • Supervise a team of regulatory professionals. • Perform other duties as assigned. Qualifications: Required: • Four years of relevant experience. Preferred: • Five years in regulatory affairs/compliance • Experience working with the FDA • Oncology/Cell and Gene therapy experience • Strong computer skills and excellent organizational skills Company: Baylor College of Medicine, located in the Texas Medical Center, is a health sciences university located in Houston, Texas Founded in 1900, the company is headquartered in Houston, Texas, USA, with a team of 5001-10000 employees. The company is currently Late Stage. Baylor College of Medicine has a track record of offering H1B sponsorships. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionProduct Management IndustriesSoftware Development Referrals increase your chances of interviewing at Jobright.ai by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for “Regulatory Affairs Manager” roles. Houston, TX $160,000.00-$213,000.00 3 weeks ago Greater Houston $70,000.00-$80,000.00 3 weeks ago Senior Manager, CIB & Research Compliance Officer Houston, TX $100,000.00-$190,000.00 2 weeks ago Houston, TX $69,700.00-$104,600.00 1 week ago Houston, TX $103,000.00-$139,000.00 1 week ago Houston, TX $98,300.00-$161,000.00 3 days ago Manager, Reliability Compliance, Transmission Houston, TX $102,000.00-$128,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Mid-Level Manager, Regulatory Affairs
role at
Jobright.ai
Qualifications, skills, and all relevant experience needed for this role can be found in the full description below. 1 day ago Be among the first 25 applicants Join to apply for the
Mid-Level Manager, Regulatory Affairs
role at
Jobright.ai Get AI-powered advice on this job and more exclusive features. Jobright is an AI-powered career platform that helps job seekers discover the top opportunities in the US. We are NOT a staffing agency. Jobright does not hire directly for these positions. We connect you with verified openings from employers you can trust. Job Summary: Baylor College of Medicine is seeking a Regulatory Affairs Manager to provide analytical, regulatory, and supervisory support for the clinical research team at The Center for Cell and Gene Therapy. The role involves training regulatory staff, developing regulatory strategies, and ensuring compliance with federal regulations and institutional policies. Responsibilities: • Maintain timely knowledge of federal regulations, institutional policies and ICH GCP guidelines in order to properly guide regulatory staff and investigators in preparing projects that are in compliance with those documents. • Responsible for confirming the content of regulatory submissions. • Work with the regulatory staff and investigators in developing protocol documents and consent forms as necessary, works with regulatory staff and investigators to assist in responding to queries from institutional review committees and other regulatory agencies including the FDA. As necessary submits and maintains such documents. • Assist and prepare for FDA meetings, inspections, and audits from regulatory agencies. • Help to maintain systems meant to optimize communication of changes in regulatory processes to investigators, regulatory staff, and other involved parties. • Help to maintain systems meant to optimize protocol specific information distribution to investigators, research staff, and other health care providers. • Assist in submission and maintenance of regulatory documents as needed to ensure that all clinical research projects remain open and are conducted in compliance with all regulations and policies (federal and local). • Supervise a team of regulatory professionals. • Perform other duties as assigned. Qualifications: Required: • Four years of relevant experience. Preferred: • Five years in regulatory affairs/compliance • Experience working with the FDA • Oncology/Cell and Gene therapy experience • Strong computer skills and excellent organizational skills Company: Baylor College of Medicine, located in the Texas Medical Center, is a health sciences university located in Houston, Texas Founded in 1900, the company is headquartered in Houston, Texas, USA, with a team of 5001-10000 employees. The company is currently Late Stage. Baylor College of Medicine has a track record of offering H1B sponsorships. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionProduct Management IndustriesSoftware Development Referrals increase your chances of interviewing at Jobright.ai by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for “Regulatory Affairs Manager” roles. Houston, TX $160,000.00-$213,000.00 3 weeks ago Greater Houston $70,000.00-$80,000.00 3 weeks ago Senior Manager, CIB & Research Compliance Officer Houston, TX $100,000.00-$190,000.00 2 weeks ago Houston, TX $69,700.00-$104,600.00 1 week ago Houston, TX $103,000.00-$139,000.00 1 week ago Houston, TX $98,300.00-$161,000.00 3 days ago Manager, Reliability Compliance, Transmission Houston, TX $102,000.00-$128,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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