-
Specialist, Regulatory Affairs
1 week ago
Edwards Lifesciences Irvine, United StatesMake a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorit ...
-
Regulatory Affairs Specialist, Selution
1 week ago
Cordis Irvine, United StatesOverview: · MedAlliance is a leading and innovative combination medical device company dedicated to improving patient outcomes and enhancing healthcare worldwide. We specialize in the development, manufacturing, and commercialization of cutting-edge coronary and peripheral medica ...
-
Regulatory Affairs Specialist Temp
1 week ago
Nihon Kohden Irvine, United StatesThe Regulatory Affairs Specialist temp is responsible for developing and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory approval for the organization's products. Work with RA Leadership and other members of the RA team ...
-
Regulatory Affairs Manager
1 week ago
McGuff Family of Companies Santa Ana, United States**The McGuff Company Inc. is growing and looking to hire a Regulatory Affairs Manager** · McGuff values its employees as one of its most important resources. We strive for a vibrant, healthy work culture and attain it through good communication, active involvement, and corporate ...
-
Regulatory Affairs Associate
1 week ago
Hycor Biomedical, LLC Garden Grove, United StatesThe Regulatory Affairs Specialist will assist in regulatory submissions, interpret regulations, and provide regulatory guidance. This role will be responsible for preparing submission documents and work cross-functionally with other departments to ensure timely completion of deli ...
-
Regulatory Affairs Analyst(Usc/gc Only)
2 days ago
Infosoft Teksolutions Irvine, United StatesHere are the job position details for your review: · Job Title**:Regulatory Affairs Analyst (USC/GC Only & W2 ONLY)** · Pay Rate**:$50 to $55/HR** · Duration**:9 months** · Location**:Irvine, CA (Onsite)** · **Shift: 8 am to 5 pm.** · We are looking for a **Regulatory Affairs Ana ...
-
Associate Regulatory Affairs Specialist
3 days ago
Medtronic Santa Ana, United States**Associate Regulatory Affairs Specialist (hybrid)** · Cardiac surgery represents end-state treatment in the care continuum for many cardiovascular diseases. There are approximately 1.8 million cardiac surgical procedures in the world on an annual basis. Cardiac surgery remains e ...
-
Director, Regulatory Affairs
3 weeks ago
Quest Diagnostics San Juan Capistrano, United StatesOverview: · **Responsibilities**: · - Manages team of regulatory and clinical professionals at the Specialist or Manager levels · - Establishes and executes regulatory and clinical strategies, in cooperation with cross-functional project teams. · - Provides guidance to staff on i ...
-
Regulatory Affairs Consultant
3 weeks ago
Redbock - an NES Fircroft company Irvine, United StatesRegulatory Affairs Consultant · Irvine, CA · A fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a Regulatory Affairs Consultant to support them for approximately 3 months. The consultant will need to work onsite at least 3 days/week. · The Regu ...
-
Regulatory Affairs Specialist
2 weeks ago
Cypress HCM Irvine, United States· 0-2 years of experience in regulatory affairs, and/or experience in QA, R&D, Manufacturing or Project Management within the IVD industry · Working knowledge of FDA, and CE marking requirements for IVD products is a plus · Able to work independently and with others · Able to wo ...
-
Regulatory Affairs Specialist
3 weeks ago
Tucker Parker Smith Group (TPS Group) Irvine, United StatesJob Title: Regulatory Affairs Specialist · Location: Irvine, CA · Schedule: Hybrid, Monday to Friday, 8 AM to 5 PM, with on-site work Tue/Thur · Duration: 1 year with potential to extend/ convert to internal FTE · no fully remote option · hourly rate of $40-45/hr · About Us: We a ...
-
Regulatory Affairs Specialist
3 weeks ago
Kelly Science Engineering Technology & Telecom Irvine, United StatesRegulatory Affairs Specialist (hybrid) · Kelly Science and Clinical FSP is currently seeking a medical device Regulatory Affairs Specialist II for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional ...
-
Regulatory Affairs Specialist
3 weeks ago
Kelly Science, Engineering, Technology & Telecom Irvine, United StatesRegulatory Affairs Specialist (hybrid) · Kelly Science and Clinical FSP is currently seeking a medical device Regulatory Affairs Specialist II for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional S ...
-
Regulatory Affairs Specialist
20 hours ago
Kelly Services, Inc. Irvine, United StatesThe Regulatory Affairs Specialist II, will provide administrative and technical support to regulatory affairs leadership in order to facilitate compliance with U.S. and international regulatory requirements. The Regulatory Affairs Specialist provides Regulatory Affairs, Specialis ...
-
Manager, Regulatory Affairs
1 week ago
Allergan Aesthetics Irvine, United StatesJob Description · Interested in this role You can find all the relevant information in the description below. · Description · The Manager Regulatory Affairs represents US regulatory affairs for device development projects. Executes US regulatory strategic plans and provides guid ...
-
Specialist, Regulatory Affairs
3 weeks ago
Edwards Lifesciences Irvine, United StatesMake a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorit ...
-
Regulatory Affairs Specialist
1 week ago
Brett Fisher Group Irvine, United StatesJob Description · Job DescriptionThis is a rare opportunity to join the global regulatory team of an innovative, fast-paced, medical device company. The Company values intellectual curiosity, self-starters with a willingness to grow and expand their impact on the organization, em ...
-
Regulatory Affairs Consultant
3 weeks ago
Redbock - an NES Fircroft company Irvine, United StatesA fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a · Regulatory Affairs Consultant · to support them for · approximately 3 months . The consultant will need to work · onsite at least 3 days/week . · The Regulatory Affairs Consultant will ...
-
Regulatory Affairs Specialist
3 weeks ago
Kelly Science, Engineering, Technology & Telecom Irvine, United StatesRegulatory Affairs Specialist (hybrid) · Kelly Science and Clinical FSP is currently seeking a medical device Regulatory Affairs Specialist II for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional ...
-
Regulatory Affairs Consultant
2 weeks ago
Redbock - an NES Fircroft company Irvine, United StatesRegulatory Affairs Consultant · Irvine, CA · A fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a · Regulatory Affairs Consultant · to support them for · approximately 3 months . The consultant will need to work · onsite at least 3 days/wee ...
Director, Regulatory Affairs - Irvine, CA, United States - Tarsus Pharmaceuticals
Description
About the RoleThe Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products, with a focus on US regulatory affairs both pre- and post-approval.
Experience in development and clinical regulatory activities and providing regulatory leadership on the project teams in this area is required.
The candidate will also directly provide or oversee pre- and post-approval submissions activities.Let's talk about some of the key responsibilities of the role:
Provide regulatory leadership on the project teams, with a focus on development and clinical regulatory affairs, but with good knowledge of other areas of regulatory affairs.
Work with project teams to resolve complex project issues utilizing regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements.
Work in close collaboration with other functional leads to plan, prioritize, supervise and/or conduct project activities.Provide interpretation of regulatory authorities' feedback, policies and guidelines.
Develop regulatory strategic plans, either directly or in conjunction with project teams.
Lead or oversee the preparation of regulatory submissions for assigned projects; responsible for quality and timeliness of IND/CTA/NDA/MAA and post-approval submissions.
Work with cross-functional partners and contractors in the preparation, review, and completion of documents for regulatory submissions.Factors for Success:
Advanced degree (MD, PhD or PharmD)Minimum of 10 years of regulatory affairs experienceStrong interpersonal skills, both written and verbal, are desired.
Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills evidenced by past performance on drug development project teams.
Ability to thrive in a fast-paced, entrepreneurial environment.Ability to function at a high level in a team setting or acting as an individual contributor.
An excellent understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
A high attention to detail and ability to coordinate and prioritize assigned projects.
A Few Other Details Worth Mentioning:
The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals.
We provide a hybrid work environment and remote work is an option.We are passionate about our culture Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impactThis position reports directly to our VP, Regulatory Affairs.
Some travel may be required – up to 10%.At Tarsus, we understand the importance of attracting and retaining top talent.
The expected base pay range for this position is $181,200 - $235,600 plus bonus, stock equity, and comprehensive benefits.The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training.
Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days.For more details regarding Tarsus benefits, please visit:
. #LI-RemoteTarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.