Associate Director, Regulatory CMC – Small Molecule
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Job Description
Regulatory professional managing small molecule CMC projects at BeOne, focusing on regulatory strategies and submissions for cancer treatments.
Responsibilities:
- Manage, evaluate, and complete regulatory projects consistent with company goals
- Lead, develop and implement small molecule CMC regulatory strategies
- Authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global submissions
- Develop regulatory strategy and execute in the preparation of timely responses
- Work collaboratively with cross-functional leads and communicates CMC regulatory strategies
- Lead regulatory risk assessment, identify key CMC regulatory issues
- Provide CMC regulatory review for clinical protocols and investigator brochures for the assigned project
Requirements:
- 8+ years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience
- BA/BS Degree in scientific disciplines, MS/PhD preferred
- Proven record of leading Health Authority interactions
- In-depth knowledge of ICH requirements and US/EU regulatory requirements
- Knowledge/experience with regulatory requirements for rest of world regions and GMP regulation is a plus
- Experience in authoring complex technical documents, CTD M2 and M3 sections, and life cycle management
- Excellent oral and written communications skills are a must-have
- Detail-oriented, self-motivated, and comfortable with broad responsibilities
Benefits:
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
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