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Regulatory Affairs Specialist-4694
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Infosoft Palo Alto, United StatesOne of our clients is looking for a talented and highly motivated **Sr. Regulatory Affairs Specialist**. Please **send your resume** if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position. · Here are the job position details for ...
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Regulatory Affairs Specialist(W2 Only)
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Infosoft Teksolutions Palo Alto, United StatesHere are the job position details for your review: · Job Title**:Regulatory Affairs Specialist (W2 Only)** · Pay Rate**:$63 to $68.89/HR** · Duration**:12 months** · Location**:Palo Alto, CA (Hybrid - 2 days/week onsite)** · **Must have skills on the Resume**: · - **Product Regis ...
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Regulatory Affairs Director
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Coherus BioSciences Redwood City, CA, United StatesTitle: Director, Compliance · Reports To: Head of Quality · Location: Redwood City, California · Classification: Exempt · Overview: · Principle Responsibilities and Duties: This position is responsible for establishing and implementing global compliance systems for operation ...
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Cytokinetics South San Francisco, United StatesReporting to the Senior Director, Regulatory Affairs, the Associate Director of Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies. · **Responsibilities** ...
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Senior Director Regulatory Affairs
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Meet Redwood City, United StatesExciting Opportunity in Regulatory Affairs - Sr. Director · Location: Redwood City, CA (Onsite 3 days per week) · Company Overview: · A pioneering biotechnology company, at the forefront of cortisol modulation research and development, is seeking a dynamic Regulatory Affairs Sr. ...
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Senior Regulatory Affairs Specialist
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Nevro Redwood City, United StatesBachelor's degree and a minimum of 4 years of experience in medical devices, OR Advanced degree in a scientific discipline with a minimum of 3 years of experience in medical devices. Experience working with Class III medical devices (PMA, IDE, EU MDR Regulatory Affairs, Specialis ...
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Senior Regulatory Affairs Specialist
1 week ago
Pulmonx Redwood City, United StatesPulmonx is looking for an experienced Sr Regulatory Affairs Specialist to join our dynamic Regulatory Affairs Team in Redwood City, CA · Is this your next job Read the full description below to find out, and do not hesitate to make an application. · Not sure who Pulmonx is and ...
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Senior Regulatory Affairs Specialist
2 weeks ago
Pulmonx Redwood City, United StatesPulmonx · is looking for an experienced · Sr Regulatory Affairs Specialist · to join our dynamic Regulatory Affairs Team in Redwood City, CA · Not sure who Pulmonx is and how our Zephyr valves help people to breathe better? Check out some of the videos on our YouTube Channel: ...
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Senior Regulatory Affairs Specialist
3 weeks ago
Pulmonx Redwood City, United StatesPulmonx is looking for an experienced Sr Regulatory Affairs Specialist to join our dynamic Regulatory Affairs Team in Redwood City, CA · Not sure who Pulmonx is and how our Zephyr valves help people to breathe better? Check out some of the videos on our YouTube Channel: · Respon ...
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Senior Regulatory Affairs Specialist
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Pulmonx Corporation Redwood City, CA, United StatesPulmonx is looking for an experienced Sr Regulatory Affairs Specialist to join our dynamic Regulatory Affairs Team in Redwood City, CA · Not sure who Pulmonx is and how our Zephyr valves help people to breathe better? Check out some of the videos on our YouTube Channel: · Respon ...
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Senior Regulatory Affairs Specialist
3 weeks ago
Pulmonx Redwood City, United StatesPulmonx is looking for an experienced Sr Regulatory Affairs Specialist to join our dynamic Regulatory Affairs Team in Redwood City, CANot sure who Pulmonx is and how our Zephyr valves help people to breathe better? Check out some of the videos on our YouTube Channel: and capabili ...
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Senior Regulatory Affairs Specialist
3 weeks ago
Pulmonx Redwood City, United StatesPulmonx is looking for an experienced Sr Regulatory Affairs Specialist to join our dynamic Regulatory Affairs Team in Redwood City, CA · Not sure who Pulmonx is and how our Zephyr valves help people to breathe better? Check out some of the videos on our YouTube Channel: · Resp ...
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Senior Regulatory Affairs Specialist
3 weeks ago
Pulmonx Redwood City, CA, United StatesPulmonx is looking for an experienced Sr Regulatory Affairs Specialist to join our dynamic Regulatory Affairs Team in Redwood City, CA · Not sure who Pulmonx is and how our Zephyr valves help people to breathe better? Check out some of the videos on our YouTube Channel: · Respon ...
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Senior Regulatory Affairs Specialist
1 week ago
Pulmonx Redwood City, United StatesPulmonx is looking for an experienced Sr Regulatory Affairs Specialist to join our dynamic Regulatory Affairs Team in Redwood City, CA · Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements. · Not sure who ...
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Senior Regulatory Affairs Specialist
2 weeks ago
Nevro Redwood City, United StatesAbout NevroNevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company s ...
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Senior Regulatory Affairs Specialist
6 days ago
Nevro Redwood City, United StatesAbout Nevro: · Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The compa ...
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Senior Regulatory Affairs Specialist
3 weeks ago
Nevro Redwood City, CA, United StatesAbout Nevro · Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The compa ...
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Senior Regulatory Affairs Specialist
5 days ago
Nevro Redwood City, United StatesAbout Nevro: · Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The comp ...
Senior Director Regulatory Affairs - Redwood City, United States - Meet
Description
Exciting Opportunity in Regulatory Affairs - Sr. DirectorLocation:
Redwood City, CA (Onsite 3 days per week)
Company Overview:
A pioneering biotechnology company, at the forefront of cortisol modulation research and development, is seeking a dynamic Regulatory Affairs Sr.
Role Overview:
As a Regulatory Affairs Sr.
Director focused on oncology products, you will lead regulatory strategy, filings, and health authority interactions, providing strategic and operational leadership to support the development of innovative drug products.
This role requires a strong understanding of global regulations and extensive experience in regulatory affairs within the biotechnology or pharmaceutical industries.
Responsibilities:
Develop global regulatory plans to support programs in all phases of development, identifying risk mitigation strategies and influencing project teams to maximize regulatory success.
Manage regulatory documents/submissions for IND/CTA and marketing applications.
Prepare for and attend meetings and teleconferences with regulatory agencies.
Monitor changes in global regulations governing drug development and contribute to process improvements.
Preferred Skills and Qualifications:
10+ years of experience in Regulatory Affairs in biotechnology or pharmaceutical industries.
Extensive drug development experience with a focus on regulatory strategies.
Experience preparing global regulatory submissions including INDs, CTAs, and marketing applications.
Familiarity with Electronic Common Technical Document format and regulatory inspection readiness.
Ability to travel to agency meetings (US and international).
Senior management experience with the ability to develop and lead a team.
Excellent verbal and written communication skills.
Preferred Education:
PhD in a scientific discipline, Medical Degree, or PharmD.
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