Associate Director Regulatory Affairs
21 hours ago
Title: Associate Director of Regulatory Strategy
A rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented Associate Director of Regulatory Strategy. This role will lead regulatory strategy for drug-device combination product development.
Key Responsibilities
- Serve as the global regulatory lead for assigned development programs and marketed products, with primary ownership of drug-device combination product strategy and a collaborative role in clinical and nonclinical planning.
- Prepare and represent the company in FDA and global Health Authority meetings (Type A/B/C, INTERACT, Scientific Advice), with particular focus on CMC, clinical, and combination product matters.
- Lead regulatory planning, authoring, and review of INDs, NDAs, BLAs, supplements, and briefing documents-ensuring strategic alignment and technical rigor.
- Provide strategic regulatory leadership across drug substance, drug product, device components, manufacturing processes, and packaging/labeling-particularly for injectable and inhalation drug-device combinations. This includes conducting change control impact assessments and preparing associated regulatory submissions to implement post-approval changes for marketed products in compliance with regulatory requirements.
- Partner with Technical Operations, Quality, Clinical, and Commercial functions to proactively identify and mitigate regulatory risks, support global change control processes, and provide strategic regulatory input to development and lifecycle management plans from early development through late-stage and post-commercialization activities.
- Contribute to internal regulatory policy, participate in industry forums, and engage with thought leaders to ensure the organization remains at the forefront of combination product innovation.
Qualifications
- Bachelor's Degree in Life Science or Engineering with 12+ years of progressive regulatory experience, a Master's Degree with 8+ years, or a Ph.D. with 5+ years in biotech or pharma, with substantial responsibility for Regulatory across all stages of development.
- Experience with combination products (e.g., inhaled, injectable, or wearable systems) and an understanding of applicable FDA regulations and guidance (e.g., Human Factors, bridging strategies).
- Experience with global regulatory submissions (e.g., US FDA, EMA, Health Canada, PMDA).
- Familiarity with 505(b)(2) development strategies or innovative delivery platforms.
- Interest in mentoring or shaping regulatory frameworks in emerging therapeutic areas.
- Proven track record of successful interactions with the FDA and/or global regulatory agencies.
- Comfortable collaborating across disciplines to influence clinical development plans and contribute to integrated regulatory strategies.
- Strong writing, communication, and leadership skills-with the ability to translate complex issues into actionable strategies.
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