Principal Regulatory Affairs Strategy Associate

🚀 Principal Regulatory Affairs Strategy Associate

Hourly Rate $83.33 per hour W2

📍 Lake Forest, CA (100% Onsite)

💼 W2 Contract through Source One Technical Solutions

📅 6–8 Month Assignment with Potential Extension

❌ No C2C | No Sponsorship Available

Source One Technical Solutions is seeking a Principal Regulatory Affairs Strategy Associate to support a global leader in ophthalmology, medical devices, and pharmaceutical products.

This is a high-impact regulatory leadership role responsible for developing and executing regulatory strategies across ophthalmic product portfolios, supporting new product introductions, sustaining existing products, and driving successful regulatory submissions and approvals. The selected professional will work closely with cross-functional teams, senior leadership, manufacturing sites, and regulatory authorities to ensure compliance and support business growth initiatives.

Key Responsibilities

• Develop and execute regulatory strategies for ophthalmic medical device and pharmaceutical products

• Lead regulatory activities for new product introductions, product changes, renewals, and lifecycle management

• Coordinate submissions, registrations, approvals, and regulatory communications with health authorities

• Provide strategic regulatory guidance to cross-functional teams throughout the product lifecycle

• Support Business Development, Licensing, due diligence, and integration activities

• Review and approve promotional materials to ensure compliance with applicable regulations and industry standards

• Ensure adherence to GxP requirements, SOPs, and quality system procedures

• Influence business decisions by identifying regulatory risks and opportunities

• Lead multiple regulatory projects while driving timelines and deliverables

Required Qualifications

✔ Bachelor's Degree required (advanced degree preferred)

✔ 7 years of Regulatory Affairs experience

✔ 5 years of leadership experience within Regulatory Affairs

✔ Experience supporting medical device and/or pharmaceutical products

✔ Strong understanding of global regulatory requirements and product registration processes

✔ Experience developing regulatory strategies and managing submissions

✔ Excellent project management, communication, and stakeholder management skills

✔ Ability to operate independently in a fast-paced, highly regulated environment

Preferred Experience

• Ophthalmology, vision care, medical device, pharmaceutical, or healthcare product experience

• New product development and commercialization support

• Regulatory strategy for global product portfolios

• Product lifecycle management and change control activities

• Promotional material review and compliance oversight

• Experience working with cross-functional teams including R&D, Quality, Clinical, Marketing, and Manufacturing

Why Apply?

This opportunity offers the chance to join a world-class healthcare organization and play a critical role in shaping regulatory strategy for innovative ophthalmic products impacting patients worldwide.

📩 Interested candidates are encouraged to apply today.

Source One Technical Solutions

A WBENC Certified Company