- 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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Director of Regulatory Affairs
4 weeks ago
Evestra, Inc. San Antonio, United StatesOur 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 te ...
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Regulatory Affairs Manager
4 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 Manager
1 day ago
RegenTx San Antonio, United StatesThe 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 audit agenda, plan, summary reports for internal audits. · ...
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Regulatory Affairs Analyst
1 week 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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Regulatory Affairs Analyst
3 days ago
UT Health San Antonio San Antonio, United StatesJob Description · Under minimal supervision, responsible for assisting with obtaining government approval for new products that are covered by government regulations, including the preparation of marketing applications. · ResponsibilitiesPrepares or oversees annual progress rep ...
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Regulatory Affairs Coordinator
4 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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Regulatory Affairs Assistant
2 weeks 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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Regulatory Affairs Manager-Product Development
4 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 & Medical Affairs Liaison
2 weeks 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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Head, Corporate
4 weeks ago
Cornerstone Search Group San Antonio, United StatesHead, Corporate & Legal Affairs – Strategic Advisor Reporting to CEO; · Innovative CRO – Remote – Retained Search · Summary: · Cornerstone Search Group has been retained by a rapidly growing Clinical Research Organization funded by a thriving multi-billion-dollar parent Health C ...
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Senior Investment Consultant
3 weeks ago
Cetera Investment Services LLC San Antonio, United StatesWe are looking for a motivated individual to fill the role of a Senior Investment Consultant for Hancock Whitney Financial Consultants located at Hancock Whitney Bank in San Antonio, TX · JOB FUNCTION / SUMMARY: · Senior Investment Consultants are primarily responsible for consul ...
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Senior Investment Consultant
2 weeks ago
Cetera Investment Services LLC San Antonio, United StatesWe are looking for a motivated individual to fill the role of a Senior Investment Consultant for Hancock Whitney Financial Consultants located at Hancock Whitney Bank in San Antonio, TXJOB FUNCTION / SUMMARY:Senior Investment Consultants are primarily responsible for consulting w ...
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Health Economics and Outcomes Research
4 weeks ago
Thermo Fisher Scientific San Antonio, United States Full timeAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – to enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources neede ...
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Director of Research
2 days ago
Extremity Care San Antonio, United StatesJob Description · Job DescriptionSalary: $126,600.00 · Purpose: · The Director of Research & Product Development will be responsible for leading all new product development (NPD) initiatives for RegenTX Labs. This role will be responsible for planning and driving product strategy ...
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Clinical Coordination Support
2 days ago
LADGOV CORPORATION San Antonio, United StatesJob Title: CLINICAL COORDINATION SUPPORT · Location: JBSA Ft Sam Houston, TX78234 · Duties: · Serve as a clinical liaison to communicate information and feedback between METC programs, Program Clinical Coordinators, METC Clinical Coordinator, Dean of Academic Affairs, Associate D ...
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Branch President
1 week ago
Orion Talent San Antonio, United StatesPosition Details : · •Title: Branch President · •Location: San Antonio, TX · •Travel/Schedule: You can expect travel up to 20% of the time for periodic corporate meetings and industry events, and you will be expected to work out of the local office when not travelling and/or trav ...
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Director of Production
5 hours ago
RegenTx San Antonio, United StatesPurpose: · The Director of Production is responsible for overseeing all production staff and all production activities to ensure continuity of production to support organizational goals. · Duties & Responsibilities: · Direct and oversee the manufacture of products, ensuring produ ...
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Podiatrist (Chief-Surgical Services)
5 days ago
Veterans Health Administration San Antonio, United States Full timeSummary · The South Texas Veterans Health Care System is seeking a Podiatrist (Chief, Surgical Services) who demonstrates leadership abilities and overseeing surgical programs at the Audie L Murphy Memorial Hospital in San Antonio, TX. · Qualifications · Basic Requirements: · • U ...
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Product Manager
4 weeks ago
Extremity Care San Antonio, United StatesJob Description · Job DescriptionSalary: $80,000.00 · Purpose: · The Product Manager will lead the market launch of new products and support existing products. The Product Manager will represent both the voice of the business and the voice of the customer for product development ...
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Admissions Counselor
3 weeks ago
Facility Solutions Group San Antonio, United StatesJob Details · Job Location · 97 - Prefab - San Antonio, TX · Description · Admissions Counselor · Propel Career Academy seeks a dedicated and enthusiastic Admissions Counselor to play a vital role in recruiting and admitting students to our training and education programs. The ...
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 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 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 Managements 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
Talent Acquisition Recruiter