- Develop and oversee regulatory strategies for clinical trials in alignment with US and European regulatory requirements and industry standards.
- Lead and author the preparation and submission of regulatory documents to the FDA and EMA, including IND/CTA filings, to ensure compliance with regulatory agencies.
- Provide strategic guidance on global regulatory requirements throughout the clinical trial lifecycle, from study design to data submission.
- Serve as the primary point of contact for regulatory inquiries from internal teams, sponsors, and regulatory agencies.
- Provide leadership and mentorship to company, fostering a culture of compliance and continuous improvement.
- Collaborate with clinical operations, data management, and other functional areas to ensure regulatory requirements are integrated into clinical trial processes.
- Advanced degree in a relevant scientific or regulatory field (e.g., life sciences, pharmacy, regulatory affairs).
- At least 10+ years of experience in regulatory affairs, with a focus on clinical trials, must be in the pharmaceutical or biotechnology industry.
- Demonstrated accomplishments in achieving successful outcomes with regulatory interactions.
- Proven track record of successful regulatory submissions and interactions with regulatory agencies.
- Strong leadership skills with experience managing teams and driving cross-functional collaboration.
- Excellent communication and interpersonal skills, with the ability to effectively engage with internal and external stakeholders.
- Detail oriented with strong analytical and problem-solving abilities.
- Ability to thrive in a fast-paced, dynamic environment and adapt to changing priorities.
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Regulatory Affairs Coordinator
2 weeks ago
Evolution Research Group San Antonio, United StatesJob Details · Job Location · LOC004 ECT Endeavor Clinical Trials LLC - San Antonio, TX · Regulatory Affairs Coordinator · Job Title: Regulatory Affairs Coordinator · Location: San Antonio, Texas · About us: · ERG is a leading U.S. based, privately held, independent clinical r ...
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Director of Regulatory Affairs
3 weeks ago
Evestra Inc. San Antonio, United StatesOur Company: · Evestra, Inc. is an emerging biopharmaceutical company that focuses on developing and commercializing womens healthcare products. Based in San Antonio, Texas, Evestras mission is to improve the health and well-being of women around the world through innovative tec ...
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Regulatory Affairs Analyst
4 days ago
UT Health San Antonio San Antonio, United StatesJob Summary: · Under general supervision, responsible for assisting with obtaining government approval for new products that are covered by government regulations, including the preparation of marketing applications. · Job Duties: · * Prepares and submits new studies and amendmen ...
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Director of Regulatory Affairs
3 weeks ago
RegenTx San Antonio, United StatesThe Director of Regulatory Affairs is responsible for overseeing all regulatory matters, to include the regulatory framework, submissions, and functions to ensure that the quality management system and operational functions are compliant with FDA and state requirements, AATB Stan ...
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Regulatory Affairs Manager
2 weeks ago
Extremity Care San Antonio, United StatesJob Description · Job DescriptionSalary: $90K · Purpose: · The Regulatory Affairs Manager is responsible for managing the regulatory affairs department and functions to ensure regulatory compliance of quality management system. · Duties & Responsibilities: · Review and approve au ...
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Regulatory Affairs Assistant
3 weeks ago
The START Center for Cancer Care San Antonio, United StatesJob Details · Job Location · START - Phase I - San Antonio, TX · Position Type · Full Time · Education Level · High School/GED · Travel Percentage · None · Job Shift · Day · Job Category · Research · DescriptionStamp and distribute all incoming departmental mail · Pr ...
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Regulatory Affairs Assistant
1 week ago
START Center for Cancer Research San Antonio, United StatesJob Description · Job DescriptionStamp and distribute all incoming departmental mail · Prepare file folders for all new studies · Maintain regulatory files (paper and/or electronic), including IRB submissions and correspondence for assigned studies · Complete and obtain signature ...
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Senior Regulatory Affairs Specialist
4 days ago
ClinChoice San Antonio, United StatesPosition: Senior Regulatory Affairs Specialist · Employment type: 1 year Contract/ Permanent · Location: Jacksonville, FL or Irvine CA - 2 days per week - REMOTE FOR THE RIGHT CANDIDATE · ClinChoice is a global CRO that offers high-quality one-stop service to biopharmaceutical, m ...
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Regulatory & Medical Affairs Liaison
1 week ago
University Health San Antonio, TX, United States Full timeThe University Health Ambulatory Pharmacies are seeking a motivated Pharmacy Liaison to consent patients, to choose University Health as their preferred pharmacy, at the time of their clinic appointment. The Pharmacy Liaison will meet daily metrics by consenting patients and incr ...
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Regulatory Affairs Manager-Product Development
2 weeks ago
Extremity Care San Antonio, United StatesJob Description · Job DescriptionSalary: $90K · Purpose: · The Regulatory Affairs Manager is responsible for managing the regulatory affairs for the product development department and functions to ensure regulatory compliance of quality management system, product realization and ...
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Regulatory Affairs Associate
3 weeks ago
EKF Diagnostics Boerne, United StatesJob Type · Full-time · Description · Ensures company and products are in compliance with applicable regulations and legislation. Assists in maintaining the appropriate establishment registrations as well as product registrations and/or licensing. Assist with the preparation, co ...
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Contract Compliance Specialist
3 weeks ago
Zachry Holdings, Inc. San Antonio, United StatesThe role of the Regulatory Analyst is primarily performing as the sole liaison for regulatory affairs with any state agency with whom Zachry Exploration conducts business with. The Regulatory Analyst will also assist in Engineering Technician functions and has a high day-to-day i ...
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Randstad USA San Antonio, United States Full timejob summary: · This position is responsible for the improvement, design, development, implementation and maintenance of the GxP Quality Management System (QMS) processes as relevant to cGMP Biomanufacturing. In addition, this position will also serve as an internal Regulatory res ...
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Randstad San Antonio, United Statesmanager, quality systems and regulatory compliance. · san antonio , texas · posted 2 days ago · job details · summary · $100,000 - $125,000 per year · permanent · bachelor degree · category computer and mathematical occupations · reference · job details · job summary ...
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Randstad North America, Inc. San Antonio, United StatesThis position is responsible for the improvement, design, development, implementation and maintenance of the Gx. P Quality Management System (QMS) processes as relevant to cGMP Biomanufacturing. In addition, this position will also serve as an intern Manager, Compliance, Quality, ...
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Microsoft Corporation San Antonio, United StatesAs part of the Cloud Operations + Innovations (CO+I) organization, the Energy Markets team supports datacenter interconnection and energy supply contracts with utilities and third-party suppliers. Additionally, the team leads regulatory and policy strategy development with utilit ...
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Chief Financial Officer
3 weeks ago
San Antonio Behavioral Health San Antonio, United StatesThe CFO directs the finance and accounting functions and is integral and vital to the success of the organization. The ideal CFO candidate must possess strong problem-solving, critical thinking and analytical skills. The CFO must have an in-depth understanding of regulatory and a ...
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Contract Compliance Specialist
3 weeks ago
Zachry Group San Antonio, United StatesJob Description · The role of the Regulatory Analyst is primarily performing as the sole liaison for regulatory affairs with any state agency with whom Zachry Exploration conducts business with. The Regulatory Analyst will also assist in Engineering Technician functions and has ...
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Manager, Quality Assurance
3 weeks ago
Worldwide Clinical Trials San Antonio, United StatesWho we are · We're a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them wi ...
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Field Electonics Technician I
1 week ago
Edwards Aquifer Authority San Antonio, United StatesSalary : $42,934.74 Annually · Location : San Antonio, TX · Job Type: Full-Time - NonExempt · Job Number: · Division: External & Regulatory Affairs · Department: Regulatory Affairs · Opening Date: 05/14/2024 · Closing Date: 5/27/2024 4:30 PM Central · JOB SUMMARY · Perfo ...
Director of Regulatory Affairs - San Antonio, United States - Evestra, Inc.
Description
Our Company:
Evestra, Inc. is an emerging biopharmaceutical company that focuses on developing and commercializing women's healthcare products. Based in San Antonio, Texas, Evestra's mission is to improve the health and well-being of women around the world through innovative technologies and products.
Responsibilities:
Qualifications:
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts Management's right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Director of Regulatory Affairs professionals in San Antonio
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Leslie Salmi
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