Regulatory Affairs Director
4 weeks ago
We are seeking a highly skilled Executive Director, Regulatory Affairs to join our team at Travere Therapeutics. This individual will be responsible for developing and executing global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease.
Key Responsibilities:
- Develop and execute fast to market regulatory strategies, regulatory requirements for clinical studies, marketing approval, evidence generation and life cycle management.
- Manage interface with outside regulatory agencies and trade associations and act as an advisor/liaison to senior management in order to plan, evaluate and recommend global regulatory strategy.
- Prepare, submit and maintain product specific dossiers (IND/CTA, NDA/MAA and others as required) per local country requirements with relevant health authorities.
- Negotiate with regulatory authorities and respond to regulatory authority queries during the development and review process to ensure submission approval.
- Ensure annual licenses, registrations, listings and patent information are maintained.
- Ensure compliance with product post marketing approval requirements.
- Ensure labeling, publications, advertising and promotional items are compliant with regulatory requirements.
- Assess regulatory impacts associated with changes made in the development of products.
- Collaborate with internal stakeholders (Medical, Clinical, preclinical) and project leadership team to define or develop and obtain registration documents as required to support global development actions.
- Provide leadership with global regulatory strategy teams to ensure development of team members through the sharing of knowledge and expertise on strategic thinking and regulatory precedence reviews.
Requirements:
- Strong understanding of regulatory requirements and guidelines for the development and approval of pharmaceutical products.
- Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams and external partners.
- Ability to analyze complex data and develop effective solutions to regulatory challenges.
- Strong problem-solving skills, with the ability to think critically and strategically.
- Ability to work in a fast-paced environment and prioritize multiple tasks and deadlines.
What We Offer:
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced regulatory professional looking for a new challenge, please submit your application.
-
Regulatory Affairs Director
3 weeks ago
Salt Lake, Utah, United States Retrophin Full timeJob Summary:The Executive Director, Regulatory Affairs will lead the development and execution of global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease, ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local...
-
Regulatory Affairs Specialist
3 weeks ago
Salt Lake, Utah, United States BioFire Diagnostics Full timeRegulatory Affairs Associate Job DescriptionAt BioFire Diagnostics, we are seeking a highly skilled Regulatory Affairs Associate to join our team. As a Regulatory Affairs Associate, you will play a critical role in ensuring compliance with regulatory requirements and supporting the development of regulatory submissions.Key Responsibilities:Organize, update,...
-
Regulatory Affairs Specialist
4 weeks ago
Salt Lake, Utah, United States ICU Medical Full timeJob SummaryICU Medical is seeking a highly skilled Regulatory Affairs Specialist to provide regulatory support and guidance for the global registration of device products. The successful candidate will analyze regulatory requirements, track deliverables, and ensure full regulatory compliance of all documentation for submissions and change management.Key...
-
Regulatory Affairs Specialist
4 weeks ago
Salt Lake, Utah, United States bioMerieux Inc. Full timeJob SummaryWe are seeking a highly motivated and detail-oriented Regulatory Affairs Associate to join our team at bioMerieux Inc. The successful candidate will be responsible for supporting global regulatory partners to help fulfill regulatory requirements in different countries.Key ResponsibilitiesOrganize, update, and maintain regulatory documentation in...
-
Regulatory Affairs Specialist
4 weeks ago
Salt Lake, Utah, United States BioFire Defense, LLC Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at BioFire Defense, LLC. The successful candidate will assist the Regulatory Affairs team with formatting, assembling, and submitting timely preparation of documents for domestic and international regulatory submissions and ensuring compliance with applicable...
-
Regulatory Affairs Specialist
4 weeks ago
Salt Lake, Utah, United States BioFire Defense, LLC Full timeJob SummaryBioFire Defense, LLC is seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements for our in vitro diagnostic (IVD) products.Key ResponsibilitiesSupport the development and validation of IVD reagent test kits and their associated...
-
Compliance Director
4 weeks ago
Salt Lake, Utah, United States Professional Recruiters Full timeJob SummaryWe are seeking a highly experienced Compliance Director to lead our company's compliance efforts. The ideal candidate will have a strong background in regulatory affairs and a proven track record of designing and implementing effective internal controls.Key ResponsibilitiesDevelop and implement compliance policies and procedures to ensure...
-
Regulatory Energy Solutions Director
12 hours ago
Salt Lake, Utah, United States Mediabistro Full timeEnergy Rate Design Professional OpportunityWe are seeking a highly skilled Regulatory Energy Solutions Director to join our team in the field of utility rate design. As a key member of our solutions team, you will be responsible for delivering cutting-edge Regulatory Rate Design solutions, managing client relationships, and driving solution...
-
Decedent Affairs Coordinator
3 weeks ago
Salt Lake, Utah, United States University of Utah Full timeJob SummaryThe University of Utah is seeking a skilled Decedent Affairs Coordinator to join our team. As a key member of our hospital staff, you will be responsible for providing exceptional care and support to patients and their families during times of loss.Key ResponsibilitiesProvide assistance to hospital staff and nursing units to ensure seamless care...
-
Senior Quality and Regulatory Affairs Manager
3 weeks ago
Salt Lake, Utah, United States The Goldman Sachs Group Full timeCompliance Engineering Product Management RoleWe are seeking a talented Product Manager to join our Compliance Engineering team at The Goldman Sachs Group. As a Product Manager, you will be responsible for guiding products through all stages of their lifecycle, including research, design, scoping, delivery, promotion, and post-launch monitoring.Key...
-
Director of Quality Assurance and Compliance
4 weeks ago
Salt Lake, Utah, United States Actalent Full timeJob SummaryActalent is seeking a highly experienced Director of Quality Assurance and Compliance to lead our quality assurance team. The ideal candidate will have a strong background in quality assurance and compliance, with experience in managing internal audit programs and inspections/audits by external regulatory agencies.The Director of Quality Assurance...
-
Executive Director of Senior Living Communities
4 weeks ago
Salt Lake, Utah, United States Pinnacle Senior Living Full timeExecutive Director of Senior Living CommunitiesWe are seeking an experienced Executive Director to lead our senior living communities. The ideal candidate will have a proven track record of success in managing senior living facilities, with a focus on resident satisfaction, staff development, and regulatory compliance.Key Responsibilities:Lead and manage the...
-
Director of Governance
4 weeks ago
Salt Lake, Utah, United States American Express Full timeLead the Way in Operational Risk ManagementAt American Express, we're committed to delivering exceptional customer experiences. As a Director of Governance, you'll play a critical role in shaping our operational risk management strategy, ensuring that our organization remains agile and resilient in the face of evolving regulatory requirements and industry...
-
Food Service Director
4 weeks ago
Salt Lake, Utah, United States TWIN OAKS ASSISTED LIVING AND MEMORY CARE Full timeJob Title: Food Service DirectorAt TWIN OAKS ASSISTED LIVING AND MEMORY CARE, we are seeking a highly skilled and experienced Food Service Director to join our team. The successful candidate will be responsible for planning, directing, and monitoring the food service operations, ensuring that our residents receive high-quality meals that meet their dietary...
-
Director of Engineering
4 weeks ago
Salt Lake, Utah, United States Avolve Software Group Full timeJob Title: Director of EngineeringWe are seeking an experienced and collaborative Director of Engineering to join our Product and Development team at Avolve Software Group. This role involves driving innovation and developing successful SaaS software solutions for government clients.Key Responsibilities:Strategic Leadership: Develop and execute the...
-
Food and Beverage Director
4 weeks ago
Salt Lake, Utah, United States Azul Hospitality Full timeJob Title: Director of Food and BeverageJob Summary:We are seeking a highly experienced and skilled Director of Food and Beverage to lead our culinary team at Le Meridien Element Salt Lake City Downtown. As a key member of our management team, you will be responsible for overseeing the entire food and beverage operation, ensuring exceptional guest...
-
Strategic Operations Director
3 weeks ago
Salt Lake, Utah, United States Intercap Lending, Inc Full timeJob OverviewIntercap Lending, Inc is seeking a highly skilled Strategic Operations Director to oversee all operational aspects of our mortgage lending operations division. This role requires a strategic leader with a strong understanding of mortgage operations, regulatory requirements, underwriting guidelines and industry best practices.Key Responsibilities...
-
Senior Medical Science Liaison, West
4 weeks ago
Salt Lake, Utah, United States ThermoFisher Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Medical Science Liaison to join our team in the West region. As a key member of our Medical Affairs team, you will play a critical role in maintaining existing and developing new professional relationships with prominent healthcare providers and key decision makers in the Oncology space.Key...
-
Internal Audit Director
4 weeks ago
Salt Lake, Utah, United States Brex Full timeJob SummaryThe Director of Internal Audit will be responsible for leading Brex's internal audit function, providing independent and objective assurance on the effectiveness of the organization's risk management, control, and governance processes. This role is critical to ensuring compliance with regulatory and financial services partner requirements,...
-
Director of Population Health
4 weeks ago
Salt Lake, Utah, United States Nevada Behavioral Health Full timeLead Care Coordination TeamNevada Behavioral Health is seeking a Director of Population Health to oversee and lead a team responsible for coordinating patient care services. The ideal candidate will have a strong background in care coordination and management, with experience in developing and implementing care coordination protocols and policies.Key...