1,406 Regulatory Affairs jobs in the United States

As a Regulatory Affairs Associate, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative people around the world. Here, you will make an impact by:Performing technical activities leading to regulato Regulatory Affairs, Regulatory, Associate, Business Services, Manufacturing, Management

Direct message the job poster from Barrington James

Seeking a Regulatory Affairs Contractor (Associate Director, Global Regulatory Affairs) based along the East Coast. In this role, you will contribute to the development and execution of regulatory strategy, support global submissions, and ensure compliance across all phases of drug development. This position requires strong collaboration with cross-functional teams and regulatory authorities, with a focus on advancing new drug development and commercialization.

Key Responsibilities:

• Lead and implement regulatory strategy for assigned projects across all development phases.
• Prepare and manage INDs, CTAs, NDAs, MAAs, and related submissions.
• Collaborate with partners to align submission timelines and risk mitigation plans.
• Represent the company in meetings with regulatory agencies.
• Interpret scientific data in support of regulatory requirements and strategy.
• Provide leadership and guidance to cross-functional teams and global regulatory project teams.
• Support development of GRA processes and systems to improve efficiency.

Qualifications:

• Bachelors degree in a scientific discipline (advanced degree preferred).
• 6+ years of Regulatory Affairs experience in drug development and registration (small molecule or biologics).
• Proven track record with global submissions (EU, international markets).
• Rare disease and pediatric drug development experience strongly preferred.
• Excellent communication, teamwork, and leadership skills.
• Strong project management and computer skills.

• Seniority level Director

• Employment type Contract

• Job function Project Management, Research, and Strategy/Planning
• Industries Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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Get notified about new Regulatory Affairs Consultant jobs in Boston, MA .

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Boston, MA 200,000.00- 240,000.00 2 days ago

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Scope Of Responsibilities: He/She will be responsible for representing regulatory function to approve promotional material He/She will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision making working ac.

Responsible for assisting with ensuring compliance with US OSHA and Canadian Workplace Hazardous Materials Information System (WHMIS). This includes gathering, maintaining and correcting data into the SAP EHS database for the preparation of Safety Data Sheets (SDSs), preparation of data.

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Job Description

Seeking a Regulatory Affairs Associate to support international addendum labelling (IFUs, import labels, and country-specific labeling) for medical devices. This role involves collaboration with global RA teams and ownership of labeling compliance processes.

Job Description

Seeking a Regulatory Affairs Associate to support international addendum labelling (IFUs, import labels, and country-specific labeling) for medical devices. This role involves collaboration with global RA teams and ownership of labeling compliance processes.

Responsibilities

• Develop and design compliant labeling, including IFUs and international labels.
• Coordinate cross-functional teams and manage multiple labeling projects.
• Implement changes per international regulatory guidelines.
• Fill out forms, revue redlines and submit packages to the labeling team.
• Track labeling change requests and maintain documentation for audits.
• Monitor global regulatory trends and update internal procedures.
• Support quality system improvements and KPI reporting.
  
  

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, or related field.
• 4+ years in regulatory/quality operations within a regulated industry.
• Experience with labeling design, document control, and regulatory submissions.
• Strong knowledge of FDA and international device labeling regulations.
• Proficiency in SAP, Adobe Acrobat, and MS Office.
• Experience with Class III implantable medical devices.
• Hands-on with PMA supplements, change assessments, and audit preparation.
• Strong project coordination and stakeholder communication skills.

• Seniority level Associate

• Employment type Contract

• Job function Legal
• Industries Pharmaceutical Manufacturing

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San Jose, CA $80,000.00-$0,000.00 4 months ago

Union City, CA 100,000.00- 120,000.00 1 week ago

Sunnyvale, CA 97,600.00- 165,200.00 2 days ago

Sunnyvale, CA 97,600.00- 165,200.00 2 days ago

Sunnyvale, CA 80,900.00- 128,800.00 1 week ago

Milpitas, CA 115,000.00- 150,000.00 2 days ago

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Pleasanton, CA 115,000.00- 125,000.00 9 hours ago

Sunnyvale, CA 80,000.00- 140,000.00 7 months ago

Pleasanton, CA 112,000.00- 224,000.00 1 week ago

Santa Clara, CA 112,000.00- 224,000.00 1 month ago

San Francisco Bay Area 148,400.00- 162,400.00 1 month ago

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Primary Job Functions: Provide administrative support for the activities conducted by the Regulatory Affairs Department. Ensure timely and effective assessments of new regulatory information to determine impact on Illumina products and processes.

Secondary Job Functions: Provide support to Regulatory Affairs Department scheduling large event meetings, expense tracking and submission as well as travel planning, purchase order and vendor creation.

Responsibilities :
Gather, document and maintain regulatory intelligence information for pre-market and post market requirements in US and international countries. Monitor new and revised regulatory requirements and disseminate information to affected parties.
Support RA team in compiling and preparing hardcopy and electronic information packages for submission to regulatory agencies.
Define, monitor and receive deliverables for submissions.
Write and/or edit process documents using RA templates, or create new templates in support of continuous RA process improvement.
Perform other related duties as assigned

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Requirements: A Bachelors degree or related experience.
Demonstrated ability to work independently with new, complex technologies, office automation programs and corporate database tools to produce professional work products.
Must be productive, demonstrate the ability to deal with timeline stress, be able to cope with multiple tasks, and be able to prioritize tasks with the supervisor input.
Excellent written and oral communication skills
Must be able to gather, write, edit and facilitate assembly of memos, and process product and system information for regulatory purposes
Strong work ethic and demonstrated ability to deliver assignments on time.