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Director, Regulatory Affairs and Compliance
Galena Biopharma, Inc. is focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics. We are looking for an experienced Regulatory Affairs and Compliance professional to join our rapidly growing oncology-focused biopharmaceutical company as Director, Regulatory Affairs and Compliance, reporting to the Vice President, Regulatory Affairs and Compliance.
The successful and qualified candidate will be responsible for the planning and management of regulatory submissions to national and international health authorities and the development of strategies for global approval of Galena’s products. Overall, the Director will be a key contributor to the Regulatory department and therefore must be self-motivated, astute, flexible with ability to recognize priorities and therefore focus on the task at hand. Candidate also must be able to work in a small or virtual company environment and be able to interact positively and productively with key stakeholders, both internally and externally.
Represent senior management and serve as a regulatory leader when needed.
Prepare and drive regulatory documents preparations such as: INDs, IDEs, CTAs, annual reports, amendments as well as eCTDs (BLAs and MAAs) in a timely manner.
Provide thoughtful insights and guidance for preparation of regulatory documentation necessary for successful submissions to regulatory agencies.
Knowledge of the latest regulatory tools, i.e., electronic submissions is essential.
Engage as a direct contact to the FDA and other regulatory authorities when needed.
Communicate Regulatory and Quality (Quality Systems) requirements throughout the organization to ensure up to date GXPs compliance (review or generation of SOPs).
B.S. in Chemistry, Pharmacy, Biochemistry or other related science discipline is required.
A minimum of 6-8 years experience in Regulatory Affairs with experience in clinical trial applications and marketing submissions.
Working knowledge of regulatory requirements – US and ex-US – for development of drugs, biologics and medical devices, including in-vitro diagnostics (IVD)
Oncology experience is preferred but not required.
Advanced degree is preferred.
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