Assoc Director Reg Affairs

Role: Lead regulatory strategy development and implementation for diverse pharmaceutical products, including both in-development (brand and generic) and marketed assets. Responsibilities: independently craft regulatory plans for complex projects; manage interactions with FDA and other agencies through meetings and submissions; oversee preparation of high-quality filings such as INDs, NDAs, ANDAs, supplements, and variations; lead the Regulatory Intelligence program by researching and analyzing global regulatory landscape, guidance, and competitor activity; provide strategic guidance on legislation, guidance, and compliance to ensure successful submissions and product labels; support regulatory review of promotional materials. Requirements: BS/BA in life sciences; 3-5 years of regulatory or industry experience; strong knowledge of US and international regulatory requirements; experience with IND/NDAs/ANDAs and regulatory intelligence; excellent leadership, communication, and interpersonal skills. Preferred: advanced degrees (MS, PhD, PharmD), RAC certification. High-Value: experience leading regulatory strategies for pharmaceutical development, active engagement with FDA, regulatory intelligence expertise, and familiarity with global regulatory environment. Work Setup: office-based.