Associate Director Regulatory Affairs - Malvern, PA

The job involves regulatory review of new supplier & part qualifications. It includes submissions to EU and FDA. The candidate should be able to negotiate and build relationships with FDA, EU Notified Bodies, Health Canada etc. · The experience in preparing and submitting regulat ...

The Associate Director of Regulatory Affairs – Gene Therapy will support the development and execution of regulatory strategy for Ocugen's gene therapy portfolio. · ...

The Associate Director of Regulatory Affairs - Gene Therapy will support the development and execution of regulatory strategy for Ocugen's gene therapy portfolio. · Contribute to the design and execution of global regulatory strategy for Ocugen's gene therapy programs. · Collabor ...

The Associate Director of Regulatory Affairs – Gene Therapy will support the development and execution of regulatory strategy for Ocugen's gene therapy portfolio. · Contribute to the design and execution of global regulatory strategy for Ocugen's gene therapy programs. · Collabor ...

Description · Purpose · The Associate Director of Regulatory Affairs – Gene Therapy will support the development and execution of regulatory strategy for Ocugen's gene therapy portfolio. This role is responsible for driving regulatory submissions, providing strategic input on cli ...

The Associate Director of Regulatory Affairs – Gene Therapy will support the development and execution of regulatory strategy for Ocugen's gene therapy portfolio. This role is responsible for driving regulatory submissions and ensuring compliance with global regulatory requiremen ...

· This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. No relocation or visa sponsorship (now or in future) will be provided for this opportunity. · Who We Are · At West, we're a dedicated team that is connected by a purpose to improve ...

The Associate Director of Regulatory Affairs – Gene Therapy will support the development and execution of regulatory strategy for Ocugen's gene therapy portfolio. · ...

· Company Description · A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. ...

Lensa is a career site that helps job seekers find great jobs in the US. We are not a staffing firm or agency. Lensa does not hire directly for these jobs, but promotes jobs on LinkedIn on behalf of its direct clients, recruitment ad agencies, and marketing partners. Lensa partne ...

We Are Teva · We're Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it's innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we're dedicated to addressing patients' needs ...

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. No relocation or visa sponsorship (now or in future) will be provided for this opportunity. · Who We Are: · At West, we're a dedicated team that is connected by a purpose to improve pat ...

Cytokinetics is seeking a highly motivated Intern to join its Regulatory Affairs group. The internship will provide hands-on insights and working experience of several regulatory operations and affairs functions. · ...

We're on a mission to make good health more affordable and accessible to help millions around the world enjoy healthier lives. · ...

+Job summary · The Sr. Regulatory Affairs/Quality Specialist is responsible for leading and assisting with various regulatory submissions, authoring, and editing regulatory documentation and procedures, and participating in compliance activities. · ...

The Director of Regulatory Affairs will lead assigned projects · and all regulatory affairs activities by providing expertise · to Immunocore’s development programs.This includes developing · regulatory scientific and tactical strategies, · maintaining INDs/BLAs/MMAs, · oversee ...

+At Globus Medical we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders Our team is inspired by the needs of these patients and the surgeons who treat them We embrace a culture of exceptional response b ...

We are seeking a highly motivated Intern to join our Regulatory Affairs group at Cytokinetics. · Cytokinetics is building on its over 25 years of pioneering scientific innovations in muscle biology and advancing a pipeline of potential new medicines for patients suffering from di ...

The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, · Develop and implement medical device regulatory strategies for West's administration and safety system product portfolio with an emphasis on gaining re ...

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. · The Principal Specialist, Regulatory Affairs (Medical Devices) is responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regul ...