Regulatory Affairs Engineer

About the Company

Work with a global leader in drug delivery and combination products, delivering solutions that improve patient lives. Join a collaborative, innovative team with opportunities to grow and make an impact in international markets.

Position Details

• Contract / Part-Time
• 5–10 hours/week
• 100% Remote
• Pay: Open, based on experience

What You’ll Do

• Develop and execute CMC strategies for combination products
• Assess PK/PD impact and support device bridging (e.g., vial → autoinjector)
• Author and review CTD Module 3 and device technical documentation
• Prepare submissions for IND, BLA, NDA, and other global applications
• Respond to Health Authority inquiries on CMC and drug-device compatibility
• Track documents and coordinate with internal teams to meet deadlines
• Support global submissions (EU, APAC, LATAM)
• Contribute to risk assessments and mitigation strategies

What You’ll Need

• Bachelor’s degree in a scientific discipline
• 3–5 years Regulatory Affairs experience (pharma, biotech, or combination products)
• Experience authoring and managing regulatory submissions
• Strong understanding of CMC requirements for drugs/biologics
• Knowledge of PK/PD concepts
• Exposure to international regulatory frameworks

Nice to Have

• Familiarity with medical device standards (ISO 13485, ISO 14971)
• Experience with Design Control documentation (DHF, RMF)

Why You’ll Love It

• Work on innovative combination products impacting patients globally
• Join a collaborative, cross-functional team
• Contribute to cutting-edge regulatory strategies
• Grow your career with international exposure