The work that we do today will impact the lives, of people we do not know, in a humanistic way.
Senior Director, Regulatory Affairs
Location
United States
Posted
39 days ago
Salary
Not specified
Job Description
Job Requirements
- Bachelor’s degree in Life Sciences required
- 15+ years of Regulatory Operations experience in the pharmaceutical, biotech, or medical device industry
- 5+ years specifically in FDA Advertising & Promotion
- Proven track record in planning, managing, and submitting global eCTD regulatory dossiers
- Deep knowledge of applicable regulations (FDA- Parts 11, 211, 820), ISO, EMA, ICH, Health Canada, MHRA) and industry best practices
- Hands-on experience with eCTD publishing tools and EDMS platforms (e.g., Veeva Vault RIM, Lorenz docuBridge, Extedo, etc.)
- Experience with combination products or devices regulated under both FDA/CDER and CDRH
- Familiarity with SPL submissions, XEVMPD, and IDMP initiatives
- Knowledge of RIM implementation and structured content authoring systems
- Ability to travel up to 20%
Benefits
- Health insurance
- Paid time off
- Flexible work arrangements
- Professional development
Related Guides
Related Categories
Related Job Pages
More Compliance Jobs
Global regulatory strategy for Software as a Medical Device.
This role involves building compliance frameworks for crypto products, including AML/BSA programs and regulations related to digital assets, while collaborating with product and engineering teams.
Compliance & Risk Analyst
NayaxWelcome to Nayax, a global fintech company (NASDAQ; TASE: NYAX) dedicated to providing businesses with a comprehensive payment platform and management system for their operation. Since 2005, we've been at the forefront of the cashless payment revolution, offering innovative IoT services and management solutions for unattended retail. Driven by our customer-first mindset and a commitment to in-house development, Nayax has evolved into a leading omnichannel retail solution provider. With over 1100 talented employees located in 11 offices around the world, we proudly serve customers in more than 120 countries. We've established partnerships with several global financial institutions in order for our platform to be able to accept over 50 currencies and over 80 major forms of payment. Moreover, Nayax holds a license as a payment institution in Europe. As consumers increasingly embrace digital payment methods, Nayax continuously develops value-added services for our customers. From consumer engagement solutions and customized payment methods to an extensive API suite and a feature-rich mobile wallet app, our fully customizable management system provides an agile ecosystem that empowers merchants to improve their bottom line. Our commitment to innovation and to our customers sets us apart. Rooted in our core values, Nayax's dedicated teams consistently deliver innovative products that meet the evolving needs of retailers and consumers alike. Our mission is to empower retailers by providing them with growth tools and systems that reduce operational costs. At Nayax, we believe in creating a lasting impact on our customers' businesses, converting casual consumers into dedicated followers. By offering consumer engagement tools, loyalty programs, and omnichannel solutions, we help retailers increase their bottom line and accelerate their growth. Subscribe to our email list for the latest news on product updates, sales, and more >> https://hubs.li/Q02thqdS0
Conduct KYC/KYB checks, analyze risks, monitor transactions for compliance with AML regulations, and maintain accurate documentation in a compliance role.
Senior Manager/Associate Director of Compliance supporting a healthcare compliance program at Orca Bio
