Regulatory Affairs Strategist

Fractional Regulatory Affairs Strategist (with Global Experience Desirable) – On-Demand Pharma ConsultingLocation: Remote (Global, US/EU preferred)Employment Type: Contract/Fractional (Part-Time)Duration: Ongoing, project-based (10-20 hours/week)Compensation: $150-250/hour, based on experience and project scopeJob SummaryJoin a dynamic pharmaceutical consulting team as a Regulatory Affairs Strategist, providing expert guidance on drug development strategies. This flexible role offers the chance to work on innovative projects with leading biotech firms, leveraging your global expertise to drive successful approvals and make a real impact in advancing therapies.Key ResponsibilitiesDevelop comprehensive regulatory strategies, including gap analyses and risk assessments for drug candidates from discovery to market.Advise on pathways such as FDA 505(b)(2) or EMA scientific advice, incorporating global considerations.Prepare and review submissions, including briefing documents and responses to regulatory queries.Monitor international policy changes and provide updates on impacts to therapeutic areas like oncology or biologics.Collaborate with cross-functional teams to align regulatory plans with project timelines.Qualifications10+ years in regulatory affairs within pharma/biotech, with experience in global filings (e.g., IND/CTA, NDA/MAA).Expertise in FDA, EMA, and ICH guidelines; global experience highly desirable.Advanced degree in life sciences or regulatory science; RAC certification preferred.Strong strategic planning and communication skills.Ability to manage independent remote work.What We OfferHighly competitive hourly compensation to reward your expertise.Ultimate flexibility to balance with other commitments.Opportunities to contribute to cutting-edge pharma innovations from anywhere.Remote work with collaborative virtual tools for seamless engagement.How to ApplyTo apply, visit our career portal and complete the quick and straightforward application process: enter your details, upload your CV, add your LinkedIn (optional), answer a few qualifying questions.Apply Now(Or visit: https://www.pharmasmarket.com/signup/talent)