Computational Biology Research Assistant at QGEM developing computational models and pipelines. Responsibilities include analyzing wet lab data and collaborating with interdisciplinary teams.
About the role
- Associate Principal Scientist responsible for developing CMC regulatory strategies for pharmaceutical products. Leading regulatory submissions and managing product development requirements and strategies.
Responsibilities
- Responsible for developing and implementing CMC regulatory strategies for pharmaceutical pipeline products
- Serve as a CMC Product Lead for assigned products
- Lead development and execution of global product and project regulatory strategy(ices)
- Manage execution of CMC documentation including IND/CTA, original NDA/MAA
- Prepare and communicate CMC Risk Assessments, contingency plans, lessons learned, and escalate potential regulatory issues to management
- Partner with quality colleagues to prepare for and support pre-approval and regulatory inspections
Requirements
- B.S. in a biological science, engineering, or a related field (advanced degree preferred)
- At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields
- Proficient in English; additional language skills are a plus.
- Experience in Regulatory CMC or in preparation of regulatory filings with technical leadership skills
- Regulatory CMC experience with complex drug-device combination products/ inhalation products including nebulizers, dry powder inhalers and metered dose inhalers is required
- Familiarity with the latest global regulatory guidance’s and pharmacopeial methods
- Ability to develop innovative and imaginative approaches to problem solving
- Excellent interpersonal, verbal, and written communication, presentation, and listening skills
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays, vacation, and compassionate and sick days
- annual bonus and long-term incentive, if applicable
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