Regulatory Affairs Manager

ABOUT ORGANOX:

OrganOx has been transforming organ transplantation since 2008, leveraging groundbreaking normothermic machine perfusion technology in our flagship product, the OrganOx metra®. This technology helps preserve donor livers for up to 12 hours, in efforts to reduce organ discard rates and facilitating more successful transplants. We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes. As part of our ongoing expansion in North America, we seek a motivated Regulatory Affairs Manager to join our team.

Position Summary

The position of Regulatory Affairs Manager will work with internal and external partners to deliver innovative products to customers through the preparation of comprehensive regulatory strategies and submissions to achieve marketing approvals in North America.

This role will report directly to the VP of Global...

ABOUT ORGANOX

OrganOx has been transforming organ transplantation since 2008, leveraging groundbreaking normothermic machine perfusion technology in our flagship product, the OrganOx metra®. This technology helps preserve donor livers for up to 12 hours (US) or 24 hours (Canada/EU/UK), in efforts to reduce organ discard rates and facilitate more successful transplants. We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes. As part of our ongoing expansion in North America, we seek a motivated Global Labeling Manager to join our team.

Position Summary

The Global Labeling Manager will ensure the timely and accurate delivery of product labeling. This position will work with both internal and external stakeholders to support the labeling needs for new product launches and updates to existing products.

This role will report...

We are seeking an accomplished and results-driven Senior Manager of Regulatory Affairs for our client, one of the leading pharmaceutical companies in the San Francisco Bay Area. The post represents an excellent opportunity to take part in creative therapeutic product development and commercialization within a challenging and dynamic environment.

Overview

The Senior Manager Regulatory Affairs will lead the efforts in developing and executing regulatory strategies for our client's product portfolio. Therefore, we need an individual with expertise in global regulatory requirements, as well as excellent communication and interpersonal skills to facilitate effective working relationships within cross-functional teams.

Responsibilities

• Develop and execute global regulatory strategies for assigned products throughout their lifecycle.
• Regulatory guidance to cross-functional teams will be provided by this role on a...

Global Life Science Hub has partnered with a one-of-a-kind, global CDMO that specializes in providing comprehensive development and manufacturing services. With an additional 50% growth expected in the Kansas site before the end of Q1 2025, we’re searching for an experienced Regulatory Manager to support their next growth stage.

This is a 100% on-site role with relocation assistance available in Kansas. This is an exceptional opportunity to relocate out of any major busy cities to join one of America’s most affordable states in the Heartland of America. As the Senior Regulatory Manager, your role involves managing client and stakeholder expectations, navigating regulatory processes, and creating solutions for complex regulatory challenges that contribute to producing high-quality pharmaceutical products.

Role: Senior Regulatory Affairs Manager

Location: Kansas City, KS

Responsibilities:

• Supports...

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

We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we’re advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology.

We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. 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 are a dynamic workplace for employees to grow and develop their skills.

We promote a trusting and appreciative company culture and value colleagues...

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.

We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.

Together, we are leading the way towards a healthier and more equitable future.

Position Summary

As the Senior Manager of Regulatory Affairs, you will play a critical role in ensuring regulatory compliance and supporting the execution of our regulatory strategy for our programs in clinical development. You will collaborate closely with the global...

Symmetrio is currently recruiting a qualified individual to fill the role of Regional Manager Regulatory Affairs & Quality Americas for our client, a global medical device company. The successful candidate will be responsible for overseeing the functions and team, for the North and South Americas Region, in alignment with the department's defined directions and initiatives. You will be responsible for the execution of global & local regulatory and quality strategies and policies as defined in the departmental business plan. The role involves setting priorities and expectations for direct reports, as well as monitoring and reporting on budget, planning, and logistics. This position is based in Atlanta, GA and requires you to work in the corporate offices several days/week.

Responsibilities

• Drive departmental activities in line with the overall mission and actively contribute to defining the vision for the department.
• Collaborate...

Advanced Respiratory Technologies, Inc. is a medical device company located outside of Pittsburgh, PA that is developing a transformative artificial lung system for the treatment of chronic lung diseases. Our primary goals are: (1) to produce a means of permanent respiratory support for the hundreds of thousands of chronic lung disease patients who will not be able to receive a lung transplant and die each year and (2) Further develop our system to be utilized in treating and evacuating wounded soldiers from far-forward positions in close proximity to the battlefield to definitive care in the United States. Our company values and fosters a team based approach to accomplish these goals to transform the treatment of lung disease patients.

We are seeking a highly motivated and talented individual to join our team as an Regulatory Affairs Manager. As a key member of our Medical Devices team, you will be responsible for developing and implementing regulatory strategies for our...