Head of Regulatory Affairs
Confidential
Head of Regulatory Affairs
About the Company
Top biotechnology (BioTech) company developing innovative treatments
Industry
Biotechnology
Type
Privately Held
About the Role
The Company is seeking a Head of Regulatory Affairs to provide strategic leadership and oversight of all regulatory activities related to the development and registration of its products. This critical role involves the development and execution of regulatory strategies that ensure compliance with regional and global requirements, particularly those set forth by regulatory authorities. The successful candidate will be responsible for providing regulatory strategic input to non-clinical and clinical development programs, leading the preparation of various regulatory submissions, and serving as the primary point of contact for regulatory agencies. Key responsibilities for the Head of Regulatory Affairs at the company include organizing and overseeing the preparation, review, and submission of a range of regulatory documents, such as INDs, NDAs, BLAs, and MAAs. The role also requires staying abreast of and interpreting changes in regulations, guidelines, and legislation, as well as providing guidance on compliance issues and potential risks. The Head of Regulatory Affairs will be expected to collaborate with cross-functional teams to ensure that regulatory requirements are integrated into development plans, clinical trials, and manufacturing processes. Additionally, the role involves risk assessment, mitigation, and the development and maintenance of standard operating procedures and regulatory policies to ensure ongoing compliance.
Travel Percent
Less than 10%
Functions
- Operations
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Head of Regulatory Affairs in Austin, TX vacancy
- ...Head of Policy and Regulatory Affairs About the Company Innovative layer 1 blockchain technology company Industry Information Technology and Services Type Privately Held About the Role The Company is seeking a Head of Policy to play a pivotal role...Suggested
- ...policies, leading the strategy for state money transmitter licensing, and ensuring that all products and services comply with the regulatory landscape. Applicants for the Chief Compliance Officer position at the company should have a Bachelor’s degree, with CAMS...Suggested
- ...but are not limited to, developing and implementing compliance programs, conducting risk assessments, and providing guidance on regulatory requirements. The role is highly collaborative, involving close work with senior leaders at the firm, and requires a professional...SuggestedRemote work
- ...accessible virtual care. The ideal candidate will have a proven track record of performing "compliance discovery" - identifying regulatory gaps in nascent or scaling organizations - and building robust, scalable processes from the ground up. You must possess deep expertise...SuggestedRemote workShift work
- Chief Commercial Officer (CCO) About the Company Promising biotechnology company Industry Biotechnology Type Privately Held About the Role The Company is in search of a Chief Commercial Officer to lead its commercial strategy and drive growth through...Suggested
- ...have extensive experience in health insurance compliance, proven leadership skills, and the ability to effectively communicate with regulatory bodies and senior leadership. The role allows for remote work with some travel for board meetings and regulatory engagements. #J...Remote job
- A leading virtual care provider is seeking a Chief Compliance Officer to lead regulatory compliance efforts. The ideal candidate will have over 10 years of experience in healthcare compliance with a strong emphasis on 50-state telehealth regulations. Responsibilities include...
- Chief Commercial Officer (CCO) About the Company Disruptive provider of environmental services Industry Environmental Services Type Privately Held, Private Equity-backed About the Role The Company is seeking a Vice President of Sales & Marketing ...
$118.5k - $251.6k
...Center Compliance will serve as the Integration Manager and primary engagement lead for all new data center products, sites, regions, regulatory frameworks, and material changes impacting the Data Center Compliance (DCC) organization. This role functions as the Program...Contract workTemporary workFlexible hoursOracle
Austin, TX2 days ago$130k - $160k
...role, five days per week with the option to work from home on Thursdays. Indeed Domain Tower office, Austin. The Role The Head of HR Compliance (US) is the operational anchor and strategic advisor for Indeed Flex. Reporting to the Risk & Compliance Director,...Full timeContract workTemporary workCasual workWork at officeLocal areaImmediate startRemote workWork from homeMonday to FridayFlexible hoursShift workNight shiftAfternoon shiftIndeed Flex
Austin, TX3 days ago- ...Head of Legal and Compliance About the Company Respected pharmaceutical company Industry Pharmaceuticals Type Privately Held About the Role The Company is seeking a Head of Legal and Compliance for its U.S. business. This critical leadership role...
- ...Description The Manager of Information Security & Compliance is a key leadership role responsible for overseeing security operations and regulatory compliance initiatives. This role requires deep expertise in technology, risk management, and IT security principles, with a...
iboss
Austin, TX18 hours ago - ...plan and execute internal audits of the company’s IT processes, systems, and controls, helping ensure effective risk management and regulatory compliance , The position reports directly to the Sr. Director of IT Security and can be based in Austin, Boston, or Remote US ,...Remote work
- WHAT YOU DO AT AMD CHANGES EVERYTHING At AMD, our mission is to build great products that accelerate next-generation computing experiences-from AI and data centers, to PCs, gaming and embedded systems. Grounded in a culture of innovation and collaboration, we...
Advanced Micro Devices , Inc.
Austin, TX11 hours ago $133.43k
Integral Care in Austin, TX is seeking a Director of Grants Finance to oversee grant financial lifecycle from budget development to closeout. The role includes ensuring compliance across funding sources and supervising the grant accounting team. Ideal candidates will have...Integral Care
Austin, TX2 days ago- ...the business. Partner closely with Legal, Security Engineering, DevOps, and Engineering teams to ensure alignment on security and regulatory requirements. Conduct enterprise risk assessments and facilitate ongoing risk identification, tracking, remediation, and...Temporary workRemote workWorldwide
$130.5k - $193.6k
PayPal is seeking a Senior Manager to join its Global Regulatory Relations team in Austin, Texas. The role involves leading complex projects to address regulatory challenges, enhancing compliance processes, and mentoring junior team members. The ideal candidate has over...$200k - $250k
...portfolio, which includes new AI-powered releases that support compliance and sustainability goals, enabling customers to manage regulatory requirements, operationalize sustainable practices and complement our testing, inspection and certification services. Responsibilities...Full timeUL Solutions
Austin, TX2 days ago$70 - $80 per hour
Eastridge Workforce Solutions is committed to connecting skilled professionals with meaningful career opportunities. We are seeking a GRC Analyst to support our client's team. Created Date: April 15, 2026 Anticipated Closing Date: April 29, 2026 Job Title: ...Hourly payContract workTemporary workLocal areaMonday to FridayShift workDay shiftEastridge Workforce Solutions
Austin, TX18 hours ago- A leading gaming technology company in Austin is seeking a Manager of Software Quality Assurance. This hands-on leadership role will drive quality execution and elevate processes across engineering teams. The ideal candidate should have extensive experience in software ...
$65k
...involves developing and maintaining our Quality Management System, supervising quality control personnel, and ensuring compliance with regulatory standards. Candidates must have a Bachelor's degree in Science or Engineering and 3-5 years of relevant experience. The position...$100 per hour
...Job Summary The Sr Director of Regulatory Reporting is responsible for overseeing and managing the end-to-end regulatory reporting process... ...regulators and internal stakeholders. This role reports to the Head of Regulatory Reporting and regularly interacts with senior...Synovus
Austin, TX4 days ago$85k
...Education Code (TEC) and Texas Administrative Code (TAC) is essential. Exceptional ability to read, interpret, and apply legal, regulatory, and accreditation language to school-based operations. Strong project management skills with a proven ability to coordinate...Contract workWork at officeLocal areaFlexible hoursShift work3 days per weekKIPP Texas Public Schools
Austin, TX3 days ago- ...Sirona Essential Dental Solutions team This role develops regulatory strategies for existing, new, and modified medical devices and... ...Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching...Work at office
Katalyst Healthcares and Life Sciences
Austin, TX4 days ago - ...Head of Global Regulatory Advertising and Promotion About the Company Industry shaping biopharmaceutical company Industry Biotechnology Type Public Company About the Role The Company is seeking a Head of Global Regulatory Advertising and Promotion...
- ...challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. DESCRIPTION: As a Regulatory Affairs Manager you'll provide strategic guidance on regulatory pathways, manage submissions, and serve as a subject matter expert on...Work at office
Thermo Fisher Scientific
Austin, TX4 days ago $65k
...development and maintenance of our Quality Management System. In this role, you will ensure compliance with customer specifications and regulatory standards while managing a team of Quality Control Coordinators. The position requires a Bachelor's Degree in Science or...- ...Senior Director, Regulatory Affairs About the Company International labelling organization based in Los Angeles Industry Retail Type Privately Held About the Role The Senior Director, Regulatory Affairs will be responsible for developing and managing...Worldwide
- ...Manager, Regulatory Affairs Powered by technology and compassionate design, Parachute has reimagined the plasma donation experience into one that is easier and friendlier. Using a simple app, our members can book donations and track earnings from the palm of their...
Join Parachute
Austin, TX18 hours ago - ...administration and configuration. The ideal candidate will work collaboratively with various teams to implement technical solutions that meet regulatory requirements. Candidates should have over 5 years of relevant experience and a strong background in compliance frameworks. #J-18...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Head of Regulatory Affairs. Be the first to apply!
Related searches
- chief compliance officer Austin, TX
- regulatory scientist Austin, TX
- regulatory accountant Austin, TX
- regulatory contract Austin, TX
- regulatory Austin, TX
- regulatory technician Austin, TX
- regulatory executive Austin, TX
- regulatory engineer Austin, TX
- regulatory law Austin, TX
- regulatory coordinator Austin, TX