Regulatory Affairs: Average Salary in Boston, MA in 2024
Find out what the average Regulatory Affairs salary is in Boston, MA
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Director, Regulatory Affairs U.S. Advertising and Promotion (USAP)
Advertising and Promotion (USAP) will provide strategic regulatory advice to internal stakeholders regarding tactics and communications related to Alnylam's marketed products, investigational treatments, and disease areas to healthcare providers, patients, payers, and other audiences. Collaborate wi...
Vice President, Technical / Clinical Regulatory Affairs SME - Oncology
We're currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory...
Regulatory Affairs Operations Specialist, Ad/Promo (Remote)
As the Regulatory Affairs Operations Specialist, Ad/Promo, you will play a pivotal role in ensuring regulatory compliance and operational efficiency within our organization. Strong understanding of Regulatory Operations processes and systems including Regulatory Information Management & Document/ Da...
Regulatory Affairs Consultant
Your expertise in US and EU regulations and quality management systems will drive regulatory strategy and ensure successful regulatory submissions. Degree in a relevant field (Engineering, Life Science, Regulatory Affairs etc. You will play a key role in ensuring compliance with the regulatory requi...
Regulatory Affairs Manager
IVD or medical device FDA registration.International Device Licensing and Registrations.FDA and other inspection agencies as needed....
Senior Manager Regulatory Affairs, Strategy
As the Senior Manager/Associate Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs. Your expertise and leadership will be instrumental in navigating the complex regulatory landscap...
Sr. Director, Clinical Regulatory Affairs, Auto-Immune 2024363
This role involves developing regulatory strategies, leading interactions with regulatory authorities, overseeing regulatory submissions, serving as the global regulatory lead, collaborating with the development team, and effectively managing external vendors. Expertise in regulatory submission stru...
Associate Director/Director, Regulatory Affairs 2025096
Additional Skills, licenses, or certifications in Regulatory Affairs, with Regulatory Affairs Certification (RAC) being highly desirable. The Associate Director/Director will develop and implement global regulatory strategies, serving as the regulatory lead for clinical studies and obtaining necessa...
Director of Policy & Regulatory Affairs | Eastern US, REMOTE |$165k - $175k base + bonus
The Senior Manager/Director of Policy and Regulatory Affairs will play a pivotal role in shaping and advancing our client's strategic initiatives across PJM and regulatory landscapes. Director of Policy & Regulatory Affairs | Eastern US, REMOTE |$165k - $175k base + bonus. Are you a regulatory a...
Manager, Global Regulatory Affairs CMC
Prior experience must include: Develop the regulatory submission strategies for products in commercial and development phase by working in close coordination with the quality, manufacturing and global regulatory teams; Ensure the response to health authority queries are provided in a timely and effi...
Senior Director/Director, Global Regulatory Affairs
Senior Director/Director, Global Regulatory Affairs. Collaborate with the leadership teamto develop Regulatory Strategy as part of an integrated development plan for each Corbus asset including inclusion/adoption of accelerated regulatory pathways where possible. As a pivotal member of the Corbus Pr...
Senior Regulatory Affairs Specialist
The Senior Regulatory Affairs Specialist will support and carry out the regulatory strategy and other regulatory aspects of product development and processes for the Biofourmis pharma partnerships and DTx algorithms. Reporting to the SVP of Q&R, the Senior Regulatory Affairs Specialist will have res...
VP, Regulatory Affairs & Quality
The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality department. Acts as the company’s regulatory agent an...
Senior Director Regulatory Affairs
Manages a field team of regulatory compliance employees and provides regulatory expertise through leadership, collaboration, development, management, monitoring, analyzing, and evaluating the impact of existing trends and new initiatives related to state and federal regulatory activities. Senior Dir...
Regulatory Affairs Associate
Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes. Provide regulatory input to product lifecycle planning. Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to. Determine trade...
Sr. Regulatory Affairs Manager
Hub based location)The Senior Regulatory Affairs Manager will develop and communicate a vision for the RA function to management, including the development of global regulatory strategy in the area of regulatory submissions. Representing Philips Ultrasound Regulatory Organization in both internal au...
Regulatory Affairs Manager III
Regulatory Affairs Manager III. This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submissi...
Director, Regulatory Affairs, CMC - Combination Products
The Director, RA CMC Combination Products will work cross-functionally to lead development and implementation of global combination product/Medical Devices regulatory strategies across all applicable programs and lifecycle stages in accordance with program objectives. This position serves as the Reg...
Regulatory Affairs Manager III
Regulatory Affairs Manager III. This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submissi...
Associate Director, Global Regulatory Affairs, Precision Medicine & Digital Health
This goal must be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process and policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data. The Associate Director will b...
Senior Director, Head of Business Planning & Operations, Regulatory Affairs
The (Senior) Director, Business Planning & Operations, is responsible for managing business processes in the Alexion Regulatory Affairs team and is a member of the Alexion Regulatory Affairs Leadership Team (RALT). Senior Director, Business Planning & Operations, Regulatory Affairs. Works closely wi...
Director, Global Regulatory Affairs, Development Strategy
Director, Global Regulatory Affairs, Development Strategy. Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within Alexion (i. Providing support to regulatory affairs reviewers...
Associate Director, Regulatory Affairs CMC
Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients. As the Regulatory CMC lead for these programs, you will have the opportunity to devise and implement innovative Regulatory strateg...
Senior Regulatory Affairs Specialist
Responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, preparing US and EU submissions, and ensuring timely and high-quality execution of all regulatory deliverables. Senior Regulatory Affairs Specialist. Serve as RA Repre...
Associate Director, Regulatory Affairs Advertising & Promotion
The Associate Director, Regulatory Affairs Advertising & Promotion will be responsible for providing strategic, operational and tactical regulatory advice to internal stakeholders regarding communications about investigational product pipeline assets and approved prescription products ensuring they ...