Global Regulatory Affairs - Lexington, MA

Serve as the senior and principal regulatory affairs member of project development teams. · ...

Regulatory Affairs Manager to serve as the senior and principal regulatory affairs member of project development teams. · ...

The Regulatory Affairs Specialist supports the activities of the Regulatory Affairs Department in ensuring compliance with accreditation, licensing, and regulatory requirements. · This position assists with survey readiness, documentation management, · performance tracking, · and ...

The Regulatory Affairs Specialist supports the activities of the Regulatory Affairs Department in ensuring compliance with accreditation, licensing, and regulatory requirements. · Bachelor's degree in clinical/ healthcare management or related field; Master's degree preferred. · ...

The Director Regulatory Affairs will lead global regulatory strategy for development-stage neuroscience programs. · Works with the Sr Director to develop and direct innovative strategies in support of assigned portfolio projects. · Makes point of contact with FDA and supports coo ...

The Director, · Regulatory Affairs will lead global · regulatory strategy for development-stage · neuroscience programs. · <li_annual bonus opportunity medical dental vision life and AD&D short term long term disability 401(K) plan with match stock options flexible non-accrual pa ...

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 ...

This Director Regulatory Affairs Strategy will be responsible for developing and implementing global regulatory strategy leading to successful registration and life-cycle management of unique products for patients with hematological, pulmonary/cardiovascular, and obesity/neuromus ...

Under the general direction of the CMC Regulatory Affairs team develop a Core Dossier for Module 2.3 and Module 3 CTD sections for a marketed product. · ...

+This Director Regulatory Affairs Strategy will be responsible for developing and implementing global regulatory strategy leading to successful registration and life-cycle management of unique products for patients with hematological, pulmonary/cardiovascular, and obesity/neuromu ...

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

MannKind Corporation offers an exciting internship program in biotech industry with opportunities to work in various departments. · Assist with development of standalone Drug Master File (DMF) generation · Collaborate with Quality, Manufacturing, and R&D teams to compile required ...

MannKind Corporation is a biopharmaceutical company dedicated to transforming chronic disease care through innovative patient-centric solutions. · ...

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. · ...

Reporting to the Head of Quality, Regulatory, and Compliance, · the Director of Regulatory Affairs is responsible for executing regulatory strategies, · ensuring compliance with global regulations and leading the process to obtain · and maintain market approval for DeepHealth's p ...

As a Regulatory Affairs Specialist at Mass General Brigham, you will be responsible for ensuring compliance with regulatory requirements and maintaining an updated library of FDA regulations and guidance documents. · AUTHORS AND REVIEWS OF STANDARD OPERATING PROCEDURES,T techNICA ...

This is a Regulatory Affairs & Compliance Lead role at Sensitech, where you will be the regulatory subject-matter expert for their comprehensive product portfolio. · Develop and implement regulatory strategies for new and modified products to enable entry into target markets. · ...

Sensitech Inc., a Carrier company under the Climate Solutions Transportation (CST) segment, is a global leader in supply chain visibility solutions. Sensitech helps ensure the quality and integrity of temperature-sensitive products across the pharmaceutical, food, and industrial ...

This Director Regulatory Affairs Strategy will be responsible for developing and implementing global regulatory strategy leading to successful registration and life-cycle management of unique products for patients with hematological, pulmonary/cardiovascular, and obesity/neuromus ...