Regulatory Affairs Business Partner – US Markets

Scope Group

7d•Remote

About The Position

We are looking for an experienced Regulatory Affairs Business Partner to support our growing US business and act as a key regulatory partner across the organisation. This is a highly collaborative role, working closely with Innovation, Product Development, Quality, Commercial, Marketing and Customer Care teams to bring new products to market and maintain compliance across existing portfolios. You will provide regulatory support from product ideation through development, commercialisation and lifecycle management, helping to ensure products are compliant, commercially viable and aligned with business objectives. The role will support a diverse portfolio including medical devices, OTC medicines, cosmetics, food supplements and pharmaceutical products. The Regulatory Affairs Business Partner will be reporting to the Senior Regulatory Affairs Manager. This is a Remote role with occasional travel for team meetings.

Requirements

Experience supporting US regulatory activities.
Hands-on experience working with FDA requirements.
Experience supporting medical devices and/or OTC medicines.
Experience preparing, reviewing or supporting regulatory submissions.
Strong understanding of US labelling, claims and compliance requirements.
Experience supporting products throughout the product lifecycle.
Strong stakeholder management and communication skills.
Ability to work independently and take ownership of projects.
Degree in Life Sciences, Pharmacy, Biomedical Science, Regulatory Affairs or a related discipline.

Nice To Haves

Experience with 510(k) submissions.
Experience interacting directly with FDA.
Experience with licensed medicines or pharmaceutical products.
Exposure to NDA or post-approval pharmaceutical activities.
Experience supporting ophthalmic products in the US market.
Experience with cosmetics and food supplements.
Experience with sterile products.
Experience supporting innovation and stage-gate product development processes.
Experience working within international regulatory environments.
Experience with AI, digital tools or process improvement initiatives.

Responsibilities

Provide regulatory guidance and support for the US market.
Assess regulatory requirements and pathways for new and existing products.
Support regulatory strategy development throughout the product lifecycle.
Review product claims, labelling and promotional materials.
Monitor and interpret relevant regulatory requirements, guidance and industry developments.
Support regulatory assessments and solution driven risk evaluations.
Partner with the R&D and Ideation teams to provide early regulatory input on new product concepts.
Assess regulatory feasibility and identify potential opportunities and barriers.
Support product development projects through the stage-gate process.
Contribute to claims development and product positioning discussions.
Provide regulatory guidance throughout development and commercialisation.
Act as a trusted regulatory partner to Product Development, Commercial, Marketing, Customer Care and Quality teams.
Participate in cross-functional project teams and decision-making.
Enable commercial opportunities through solution-focused regulatory support and clear, practical recommendations.
Respond to regulatory enquiries from Customer Care, Sales and commercial teams.
Support customer-facing regulatory information requests.
Assist with product-related compliance questions and investigations.
Lead regulatory activities for assigned projects.
Coordinate regulatory deliverables and timelines.
Drive projects forward and ensure regulatory milestones are achieved.
Support FDA submissions, registrations and market maintenance activities as required.
Contribute to regulatory strategies relating to FDA pathways, including 510(k) and NDA submissions where applicable.
Support FDA interactions and correspondence where required.
Maintain regulatory records and documentation.