Director, Regulatory Strategy - Alameda, CA

+Job summary · Responsible for driving global regulatory strategies that align with asset goals. · Ensures timely preparation of organized submissions. · Provides expertise in translating regulatory requirements into practical plans. · ...

This is a Director level position responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements. · ...

Independent strategic guidance/input related to current regulatory requirements and expectations for clinical trial applications and marketing applications for development projects. · Plan submissions to HAs. · Lead regulatory interactions with HAs. · Arcellx is a public biotechn ...

Arcellx isa public clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destro ...

Manages and maintains existing Investigational New Drug (IND), Clinical Trial Application (CTA), New Drug Application (NDA), and Biologics Licensing Application (BLA) submissions and prepares amendments in compliance with guidelines and regulations. · ...

+At Gilead, we're creating a healthier world for all people. · +Develop a roadmap that fosters innovation to assist where and when CMC RA invest resources and budget. · Own continuous improvement of the operating model and capability roadmap for the CMC RA function. · ...

The Gas Strategy Regulatory Specialist Expert is responsible for all aspects of BD&I's regulatory components of our gas strategy to be compliant while supporting innovation in the way we do business to be highly effective and efficient in creating positive change. · Oversight of ...

+We are seeking an experienced VP to oversee BridgeBio's Operations and Labeling functions and support regulatory strategy as needed. · +Provide overarching leadership and strategic direction for the Regulatory Operations team. · Promote continuous learning and professional devel ...

· Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monothera ...

Olema Oncology is developing better medicines for breast cancer and beyond. The company has two lead programs: palazestrant (OP-1250) and OP-3136. · We are looking for a collaborative and driven Regulatory Affairs professional who thrives in a fast-paced environment and brings ex ...

The Gas Strategy Regulatory Specialist is responsible for all aspects of BD&I's regulatory components of our gas strategy to be compliant while supporting innovation in the way we do business to be highly effective and efficient in creating positive change. · ...

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. · ...

+Job summary · Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. · +Lead the development of the New Drug Application (NDA) · Develop innovative global regulatory strategies for the Olema portfolio of products in clinical development and life ...

· Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monothera ...

Gilead is creating a healthier world for all people by tackling diseases such as HIV, viral hepatitis and cancer working relentlessly to develop therapies that help improve lives. · We continue to fight against the world's biggest health challenges our mission requires collaborat ...

The Gas Strategy Regulatory Specialist Expert is responsible for all aspects of BD&Is regulatory components of our gas strategy to be compliant while supporting innovation in the way we do business. · Lead regulatory activities by writing testimony responding to data requests mee ...

The Gas Strategy Regulatory Specialist is responsible for all aspects of BD&I's regulatory components of our gas strategy to be compliant while supporting innovation in the way we do business. · Lead regulatory activities by writing testimony, responding to data requests, meeting ...

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the glob ...

The Senior Director of Quality Assurance and Regulatory Affairs is a critical member of the leadership team, · Sr. Director - Quality Assurance & Regulatory Affairs · Provide leadership to the existing Quality Assurance team including managers and individual contributors. · ...

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. · ...