Katalyst CRO
Regulatory Affairs Manager
Location: Boulder, CO | Salary: $105,000.00–$138,000.00 | Posted: 1 week ago
Responsibilities
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.
Requirements
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.
Seniority level Mid‑Senior level
Employment type Contract
Job function Legal
Industry Pharmaceutical Manufacturing
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Responsibilities
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.
Requirements
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.
Seniority level Mid‑Senior level
Employment type Contract
Job function Legal
Industry Pharmaceutical Manufacturing
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