Regulatory Affairs Business Partner – US Markets

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer regulatory advice and support for the US market.

• Evaluate regulatory requirements and pathways for both new and existing products.

• Assist in developing regulatory strategies throughout the product lifecycle.

• Review product claims, labeling, and promotional materials.

• Monitor and interpret regulatory requirements, guidelines, and industry trends.

• Support regulatory assessments and risk evaluations.

• Collaborate with R&D and Ideation teams on new product concepts.

• Aid product development projects through the stage-gate process.

• Provide regulatory guidance during development and commercialization phases.

• Serve as a trusted partner to Product Development, Commercial, Marketing, Customer Care, and Quality teams.

• Participate in cross-functional project teams and contribute to decision-making.

• Address regulatory inquiries and customer-facing information requests.

• Lead regulatory activities for assigned projects while coordinating deliverables and timelines.

• Assist with FDA submissions, registrations, market maintenance, and communications with the FDA.

• Maintain regulatory records and documentation.

⛳️ Requirements

• Proven experience in supporting US regulatory activities.

• Practical experience working with FDA regulations.

• Experience in supporting medical devices and/or OTC medications.

• Familiarity with preparing, reviewing, or assisting in regulatory submissions.

• Strong understanding of US labeling, claims, and compliance regulations.

• Experience supporting products throughout their lifecycle.

• Excellent stakeholder management and communication abilities.

• Capability to work independently and take ownership of projects.

• Degree in Life Sciences, Pharmacy, Biomedical Science, Regulatory Affairs, or a related field.

• Desirable: experience with 510(k) submissions.

• Desirable: direct interaction experience with the FDA.

• Desirable: familiarity with licensed medicines or pharmaceutical products.

• Desirable: exposure to NDA or post-approval pharmaceutical activities.

• Desirable: experience supporting ophthalmic products in the US market.

• Desirable: experience with cosmetics and dietary supplements.

• Desirable: experience with sterile products.

• Desirable: support experience in innovation and stage-gate product development processes.

• Desirable: experience working within international regulatory frameworks.

• Desirable: familiarity with AI, digital tools, or process improvement initiatives.

• Collaborative, proactive, creative, authentic, and relationship-focused approach.

• Ability to thrive in a fast-paced and dynamic environment.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health benefits including medical, dental, and vision coverage.

• Opportunities for professional development and career advancement.

• Flexible work arrangements to promote work-life balance.

• Collaborative and inclusive company culture.