Senior Specialist Regulatory Affairs - Alameda, CA

We are seeking a Senior Manager who will partner closely with cross-functional teams to ensure promotional and medical communication strategies are compliant with applicable regulations and internal policies. · Manage regulatory submissions of promotional materials as required. · ...

We are looking for a Senior Staff Regulatory Affairs Specialist with Neurovascular / Neurointerventional Medical Devices Industry experience to join our team. · Prepare regulatory filing including 510(k), Q-submissions and 513(g). · Support labeling materials in all forms to foll ...

Provide regulatory strategies appropriate for the stage of product development to PSC designed to maximize chances of successful and expedient registration with appropriate levels of CMC efficiency and flexibility. · Critically review and provide regulatory guidance to PSC for CM ...

The Regulatory Affairs Specialist oversees regulatory compliance for all products in accordance with local, national, and international regulations and customer requirements. · ...

We are seeking a Regulatory Affairs Specialist for a 6-month temporary contract to support regulatory activities for medical devices. · Contribute to the preparation and support of regulatory submissions and filings for U.S. FDA and other global regulatory bodies. · Assess and do ...

As a Regulatory Affairs Specialist at Sugar Bowl Bakery (SBB), you oversee regulatory compliance for all products in accordance with local national and international regulations and customer requirements. · ...

We are seeking a Regulatory Affairs Specialist for a 6-month temporary contract to support regulatory activities for medical devices. · This role combines scientific, regulatory, · and business knowledge to help ensure products meet applicable regulatory requirements across globa ...

Taiho Oncology is on a mission to improve the lives of patients with cancer and their families. They value their employees who work relentlessly to help execute this mission. · ...

Taiho Oncology is on a mission to improve the lives of patients with cancer, their families, and caregivers. · ...

We invite you to join our Regulatory Affairs team as an intern. This internship offers a unique opportunity for a motivated college student to gain hands-on experience in regulatory affairs/pharmaceutical industry by contributing to regulatory/FDA/health authority research projec ...

We invite you to join Taiho Oncology as an intern in our Regulatory Affairs team. This internship offers a unique opportunity to gain hands-on experience in regulatory affairs/pharmaceutical industry by contributing to regulatory/FDA/health authority research projects within a dy ...

Taiho Oncology is on a mission to improve the lives of patients with cancer and their families through its "People first" approach. The company values its employees who work relentlessly to execute its mission. · Participate in literature review and research to support regulatory ...

Job summary · As a Regulatory Affairs Specialist at Sugar Bowl Bakery (SBB), you oversee regulatory compliance for all products in accordance with local, national and international regulations. ResponsibilitiesEnsure compliance with FDA regulationsReview and approve product label ...

The Regulatory Affairs Associate will lead the preparation, strategy, and submission of FDA regulatory applications for medical devices.Develop end-to-end regulatory strategies that integrate clinical evidence. · Author and contribute to clinical and scientific sections of FDA su ...

This innovative patient-focused commercial-stage biopharmaceutical company is seeking a Regulatory Affairs Director to lead the development and implementation of regulatory strategy for a key oncology asset. The company offers flexible work arrangements competitive compensation s ...

We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise and background through collaboration. · ...

We are seeking a Director of Regulatory Affairs to join our team at Revolution Medicines. · ...

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless ...

The Regulatory Affairs Associate will lead the preparation and submission of FDA regulatory applications for medical devices. · ...

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. · The Senior Manager of Regulatory Affairs will provide project teams with regulatory advice and obtain and main ...

We are seeking a Director of Regulatory Affairs for Companion Diagnostics (CDx) to define and lead the end-to-end global regulatory diagnostic strategy for our portfolio. · The Global Head of Regulatory Affairs for CDx will ensure synchronized drug–diagnostic co-development from ...