Regulatory Affairs Manager

Regulatory Affairs Manager

Location:

Boulder, CO | Salary: $–$ | Posted: 1 week ago

• Identifies, obtains, compiles, authors and reviews regulatory documents concerning combination products and CMC-related issues that are needed for FDA submissions including IND and NDA/BLA submissions, NDA supplements and briefing packages for agency meetings and regional approvals.
• Answers Information Requests (IR) generated during submission review cycles.
• Develops regulatory strategies, timelines and plans for the combination product development platform.
• Prepares annual reports and keeps other annual updates or reports current.
• Reviews and assesses the regulatory impact of routine proposed manufacturing and product‑related changes, non‑conformance events and other GMP related documents; researches topics when requested.
• Tracks, documents, and communicates progress of regulatory submissions and approvals.
• Orders, tracks, and processes combination product and CMC‑related regulatory submission documentation (e.g. certificates, declarations, sample requests and COAs/COCs).
• Collaborates and routinely interfaces cross‑functionally with internal and external stakeholders (e.g. key suppliers, engineering, drug development, and quality) in the context of major manufacturing initiatives and new product introductions.
• Maintains effectiveness when experiencing major changes in work responsibilities or environment, adjusting effectively to work within new work structures, processes, requirements, or cultures.
• Evaluates and communicates impact of relevant regional regulations, local and national compliance, guidance and current regulatory environment.
• Challenges processes, remains open to ideas and changes to continuously improve, seeks better alternatives, and drives change. Other duties as assigned.

• Bachelor's or master's degree in life sciences, health informatics, computer science, or related field (Advanced degree preferred).
• Minimum 10+ years pharmaceutical Regulatory Affairs experience (with combination product, clinical and CMC experience).
• Experience with administration and drug delivery systems (auto‑injectors).
• Excellent knowledge and understanding of FDA/ISO 13485/ICH/DEA regulations and relevant guidance and standards (ISO 11608-1).
• Minimum US Class II and EU Class Ia sterile device experience and in‑depth knowledge of US FDA regulations (Title 21 CFR) and EU medical device regulations MDR 2017/745.
• History of successful US 510(k) device and EU technical files submissions.
• Advanced knowledge of 21 CFR 820/ISO 13485‑2016/ISO 14971/MIL 810h.
• Experience with regulatory inspections, PAIs and field actions.
• Solid knowledge of eCTD Quality sections and regulatory submissions experience.

Mid‑Senior level

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Pharmaceutical Manufacturing