- Develop global regulatory plans to support programs in all phases of development, identifying risk mitigation strategies and influencing project teams to maximize regulatory success.
- Support efficient conduct of development programs while ensuring compliance with global regulatory requirements and company procedures.
- 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.
- 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.
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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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University of California San Francisco San Francisco, United StatesThe analyst works independently, under the direction of the Regulatory Affairs Manager, to review cooperative and industry-sponsored protocols, revise local informed consents (ICFs), and submit review packets (protocols, ICFs, and other required documents) to the UCSF IRB and ext ...
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AbbVie South San Francisco, United States**Company Description** · **Job Description** Key Responsibilities** · - Responsible for providing regulatory strategy & support for global development. · - Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions ...
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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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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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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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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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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 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
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 · 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 · 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
4 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
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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
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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
1 week 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
1 week 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. 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. Director to join their innovative team. With a robust pipeline of over 1,000 selective proprietary cortisol modulators and a history of groundbreaking FDA approvals, this company is dedicated to advancing the possibilities of cortisol modulation to treat serious diseases across various therapeutic areas
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:
Preferred Skills and Qualifications:
Preferred Education:
PhD in a scientific discipline, Medical Degree, or PharmD.