Regulatory Associate: salario promedio en Cambridge, MA in 2024

For the expansion of our team, argenx is looking for an Associate Director of Medical Writing to contribute to the development of complex clinical, nonclinical, and safety documents for regulatory submissions. Author clinical content and project manage SME contribution of regulatory documents to dev...

The Associate Director, Regulatory Advertising & Promotion will be tasked with leading, initiating, reviewing and approving strategies for non-promotional and promotional materials to comply with regulatory requirements worldwide throughout the product life cycle. Will coordinate regulatory trai...

Prior experience must include: In the immunology and inflammation therapeutic franchise, serve as the Global and US Regulatory Strategic Lead (GRL), on the global project team (GPT) for accountable individual projects; Provide global regulatory oversight and execute regulatory activities on late-sta...

The Associate Director, primarily supports Rest of World (RoW) Regulatory CMC submissions for Apellis's products, summarize and apply international regulatory requirements, provides CMC regulatory input for Health Authority submissions, manages the compilation and review of CMC M3 sections for c...

The Associate Director of CMC Regulatory Affairs will support post-approval CMC (Chemistry, Manufacturing, and Controls) changes, as well as global Supply Chain and GMP activities for Alkermes' marketed products. Manage regulatory relationships with external CMOs and third-party packaging suppliers,...

Serve as the global regulatory lead delegate for development compounds in the oncology portfolio, responsible for setting global regulatory strategy with the GRL, representing regulatory on the development core teams, and leading the Global Regulatory Sub-teams with support from the GRL. Moderna The...

The Associate Director, Regulatory Affairs CMC is responsible for helping to derive and implement the global regulatory CMC strategy for commercial programs. Manages regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory asse...

The Associate Director, Global Regulatory Science - CMC will be responsible for leading regulatory CMC strategy and execution for a commercial product, including most notably, post-approval variations. The Associate Director will be responsible for developing US regulatory CMC strategies and collabo...

Responsible for integrating and applying knowledge of global regulations governing radiopharmaceutical drug development supporting the Company's preclinical/clinical development/commercial programs, including, developing regulatory strategy for all phases of drug development in order to progress reg...

Clinical Regulatory Writing (CReW). You will be a leader for clinical regulatory writing activities within the disease area for cross functional teams and external vendor partners. Provide expert leadership to deliver submission communication strategies and drive the authoring of large clinical subm...

The Associate Director, Regulatory Affairs will be responsible for ensuring the development and delivery of science-based, solution-oriented, and globally aligned regulatory strategies for the program(s) under his/her accountability. Develop and maintain effective relationships with regulatory agenc...

Associate Director, Regulatory CMC (Boston). The Chemistry Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for investigational and marketed products. This role also provides regulatory guidance to various cross-functional teams and ensures all applic...

As an Associate Director, Global Regulatory Affairs Marketed Products you will define, develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Demonstrates acceptable skills with increasing independence ...

Sr Associate, Regulatory Affairs Sr Associate, Regulatory Affairs sought by Karyopharm Therapeutics, Inc. Newton, MA: Manage reg submissions, publish and prep submission docs, proficiency with eCTD tools and processes, track regulatory filings, etc. ...

The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. Serve as a CMC strategist and project leader for projects/programs, providing r...

We are seeking a detail-oriented Regulatory Associate to join our Regulatory Affairs team. In this role, you will play a vital part in supporting the development and submission of regulatory documents, ensuring compliance with all regulatory standards, and facilitating the approval process for clini...

SummaryA career in our Balance Sheet Management practice, within Financial Risk and Regulatory services, will provide you with the opportunity to help business leaders embed a proactive and dynamic risk management capability and mind set into their corporate business practices. You’ll help build too...

Prior experience must include: In the immunology and inflammation therapeutic franchise, serve as the Global and US Regulatory Strategic Lead (GRL), on the global project team (GPT) for accountable individual projects; Provide global regulatory oversight and execute regulatory activities on late-sta...

As an Associate within the Regulatory Reporting External Support team, you will be responsible for providing frontline support to the firm’s external shareholders for all matters related to regulatory reporting. As part of this role, you will also be responsible for partnering more broadly across th...

As the Associate Analyst, you'll be a key member of the US Policy & Regulatory Strategy team that develops policy and regulatory positions to support a reliable, affordable, and decarbonized energy future for our electric and gas customers in the Northeast US. ...

Provide leadership related to issues of importance; provide regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory insights. Join Takeda as an Associate Director, US Advertising & Promotion Regulatory Review out of our Lexingt...

We're working closely with the C-suite at an exciting medical-device company to recruit a Director of Regulatory Affairs & Quality Assurance, who will lead the development and execution of comprehensive regulatory and quality systems. Own the regulatory function, including managing a small regulator...

The Associate Director will be accountable to the GRL and Global Regulatory Science Precision Medicine Head for development of appropriate regional Precision Medicine and Digital Health regulatory strategy(s) and their timely delivery. This goal must be achieved both as a component of an overall glo...

Track regulatory project status and informational documents. Interfacing with global regulatory partners and internal cross functional teams. Minimum of 3-6 years Regulatory Affairs experience required; biologics experience required. Clear understanding of content and organization of regulatory subm...

The Associate Director/Director Biologics CMC Regulatory Affairs will play a key role in the progression of Biologics pipeline candidates by providing regulatory affairs related oversight of key CMC development and manufacturing efforts that are currently ongoing both internally and externally throu...