Senior Director Regulatory Affairs - Waltham

The Director, Regulatory Affairs will be responsible for the strategic leadership, · development and execution of science-based, solution-oriented, · and globally aligned regulatory strategies for the program(s) · under his/her accountability.This role serves as a key · regulator ...

Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases. · ...

At GSK, we have bold ambitions for patients, aiming to positively impact health of 2.5 billion people by end of decade. · We foster culture ambitious for patients, accountable for impact and committed doing right thing making sure focus efforts accelerating significant assets mee ...

We are seeking professionals with the following required skills and qualifications to help us achieve our goals: · Bachelor's degree in Biological or Healthcare Science, with previous experience in similar strategic international regulatory affairs positions. · ...

Parexel International LLC seeks a Regulatory Affairs Consultant to prepare clinical and regulatory documentation for clinical trials. The position may telecommute from anywhere in the United States up to 5 days per week. · ...

We all share the same goal - to improve the world's health. · ...

We are currently looking for an ambitious Principal Regulatory Affairs Specialist to join our Endovascular Robotics business within Advanced Therapies. · We believe the combination of endovascular robotics, image guidance, and dedicated devices will change the way neurovascular p ...

We are seeking a Regulatory Affairs Consultant to prepare clinical and regulatory documentation for clinical trials and deliver consulting services to ensure that the company meets regulatory requirements. · ...

We are seeking a dynamic and strategic Associate Director, Regulatory Affairs to join our Regulatory Affairs team.The Associate Director of Regulatory Affairs leads the development and execution of global regulatory strategies to support the approval and lifecycle management of p ...

We are seeking a dynamic and strategic Associate Director of Regulatory Affairs leads the development · and execution of global regulatory strategies to support the approval. · of pharmaceutical products B.S/M.S.and 10+ years of work experience in pharmaceutical regulatory affair ...

+The Regulatory Affairs Specialist US is responsible for preparing regulatory submissions and documentation required for U.S. FDA approvals of high-risk medical devices. · +Bachelor's degree in Regulatory Affairs or related field · Around 3–5 years of regulatory affairs experienc ...

We are seeking an experienced Director, Regulatory CMC to provide strategic and operational leadership for Chemistry, Manufacturing, and Controls regulatory activities across a growing portfolio of development and commercial products. · ...

The Director, Regulatory Affairs, Labeling will lead and facilitate the generation of new and revision of core labeling documents in collaboration with cross-functional subject matter experts. · ...

We are seeking an individual who is talented motivated and passionate about science to join our Regulatory Strategy team as a Director of Regulatory Affairs the successful candidate will play an important role in guiding new products into the clinic and setting the stage for regi ...

We are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. · We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. · Wh ...

We are seeking a dynamic and strategic Associate Director, Regulatory Affairs to join our Regulatory Affairs team. · The Associate Director of Regulatory Affairs leads the development and execution of global regulatory strategies to support the approval and lifecycle management o ...

The Senior Director of Regulatory Affairs will develop and execute global regulatory strategies in collaboration with key stakeholders.You will serve as the global regulatory lead for our multifocal motor neuropathy (MMN) program and support other programs as needed, providing ex ...

We are passionate about creating an inclusive workplace that promotes collaboration, integrity, · and excellence. · The Director of Global Regulatory Affairs is responsible for leading regional and global cross-functional teams in · the planning preparation and delivery of compli ...

The Associate Director, Regulatory Affairs is responsible for providing strategic regulatory leadership to support the development and execution of regulatory processes to ensure timely approval of products with favorable labeling that meets the needs of the business, markets, an ...

At Viridian Therapeutics we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team's expertise in antibody discovery and engineering we have created a robust pipeline of differentiated investigational therapeutic ...

We are seeking an individual who is talented motivated and passionate about science to join our Regulatory Strategy team. · Serve as a Regulatory Lead for pipeline drug development programs and marketed products. · ...