Director of Regulatory Affairs

At Ascendis, we strive to make meaningful improvements in patients’ lives. We make business decisions on patient’s needs and we do our best every day to realize our products’ benefits for our patients.  We are driven by patients, science, and data.  We are dedicated to being curious and diligent when innovating, developing, and improving products and processes.  We are passionate about realizing our shared vision and goals.  We trust each other’s strengths, and when we face challenges, we remain optimistic and committed to working together as one team to achieve extraordinary results.

The Associate Director Regulatory Affairs, Advertising and Promotion will be an internal expert on U.S. FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products.

The Associate Director Regulatory Affairs, Advertising and Promotion is responsible for providing commercial regulatory strategy and leadership to...

Gridware exists to enhance and protect the mother of all networks: the electrical grid. The grid touches everything, and when it grinds to a halt, the consequences can be dire: wildfires burn, land is destroyed, property is damaged, progress stops, and lives are lost. Our team engineers an advanced sensing system to continuously analyze both the electrical and mechanical behavior of grid assets. Utilizing high-precision sensor arrays, the system identifies and allows preemptive mitigation of faults. The technology has been proven with utilities to bolster safety, reliability, and reduce customer outage durations. The demand for power will only increase. We protect the grid of today while we build the grid of tomorrow.

Gridware is a privately held, Series A startup backed by the best climate-tech and Silicon Valley investors. We are headquartered in the Bay Area in Northern California.

Role Description:

As the first Director of Policy...

Who is CorDx？  
 

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.  
 

Job Type: Full time  
Job Title: Associate Director of Regulatory Affairs
Location: Onsite - San Diego

Salary Range: $150,000 - $170,000

Position Summary:

The Associate Director of Regulatory Affairs will play a crucial role in leading and managing the regulatory...

About the Company:
They are a clinical-stage biotechnology company dedicated to developing a new class of medicines for cancer and autoimmune diseases. Their innovative platform leverages unique antibody technology to provide more effective treatments. Committed to revolutionizing therapeutic options, their growing pipeline of clinical and preclinical assets demonstrates a passion for improving patient outcomes.

About the Role:
They are looking for a Director of Regulatory Affairs to lead the global regulatory strategy for several key immunology programs. As the global regulatory lead (GRL), you will work cross-functionally with teams to manage regulatory submissions and approvals, ensuring compliance with international health authority standards. Your role will be crucial in driving programs through all stages of development.

Key Responsibilities:

• Develop and implement comprehensive...

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.

Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.

Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.

Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.

The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling activities across programs and stages of development, with specific responsibility for the United States and...

The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling activities across programs and stages of development, with specific responsibility for the United States and the Americas and supporting global needs as required.  

The RA Associate Director, Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Associate Director prioritizes their own work to meet agreed timelines and works both independently and in a team environment. Global coordination is also required and work with external partners may be required.  

Key responsibilities: 

·       Drive process for development and management of US & Americas labelling content for initial and updated labels, including...

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.

Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.

Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.

Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.

The Associate Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Ensures timely preparation...

The Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Provides expertise in translating regulatory requirements into practical, workable plans for project teams with international participants. May mentor and potentially supervise other regulatory professionals working on the project team and regulatory process-related topics. Requires ability to work strategically, both independently and in a team environment. The position will be based in Palo Alto, CA.

Key Responsibilities

·       Responsible for strategic and operational regulatory input for cross functional (CMC, non-clinical and clinical) areas in collaboration with other project team members and regulatory colleagues

·       Contributes to the development of global clinical regulatory plans and...

Description

Global Life Science Hub is thrilled to announce its partnership with an Artificial Intelligence biotech committed to pioneering cancer treatment through groundbreaking gene therapy methodologies. By harnessing predictive analytics, machine learning, and AI technologies, they pinpoint highly expressed genes and pioneer novel CAR-T Cell Therapies. Their innovative strategy utilizes the body’s immune system to precisely target cancer cells with unprecedented precision.

Following the remarkable success of their phase I study enrolment, their stock performance reflects their ongoing achievements, soaring by an unprecedented 300% this year alone. This exceptional growth has led to the appointment of a new Director of Regulatory Affairs, who will play a pivotal role in orchestrating the filing of a new IND.

Responsibilities:

• Define the future vision and implement strategies in close alignment with internal innovation...

Global Life Science Hub is thrilled to announce its partnership with an Artificial Intelligence biotech committed to pioneering cancer treatment through groundbreaking gene therapy methodologies. By harnessing predictive analytics, machine learning, and AI technologies, they pinpoint highly expressed genes and pioneer novel CAR-T Cell Therapies. Their innovative strategy utilizes the body’s immune system to precisely target cancer cells with unprecedented precision.

Following the remarkable success of their phase I study enrolment, their stock performance reflects their ongoing achievements, soaring by an unprecedented 300% this year alone. This exceptional growth has led to the appointment of a new Director of Regulatory Affairs, who will play a pivotal role in orchestrating the filing of a new IND.

Responsibilities:

• Define the future vision and implement strategies in close alignment with internal innovation initiatives
• Lead all...

Global Life Science Hub partners with a forward-thinking New Jersey based biopharmaceutical powerhouse that is revolutionizing the life science industry. Their breakthrough innovations in oncology offer new hope to cancer patients, while their advancements in CNS disorders and infectious diseases bring relief to those facing challenging health conditions.

With a proven track record of successfully discovering and commercializing over 15 drugs, this industry leader pushes the boundaries of medical innovation. As the Director of US Regulatory Affairs, your role is to manage, design, and implement the U.S. regulatory strategy for the clinical-stage programs. You will also provide guidance on US regulatory strategy and filings.

Responsibilities:

• Direct and coordinate activities of assigned products within Regulatory Affairs, encompassing developmental products and post-marketing commitments, for a leading pharmaceutical company
• Serve...