Associate Director, Regulatory CMC – Small Molecule
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $142,000 - $192,000 per year
Job Level
Senior
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory CMC experienceauthoring CTD CMC sectionsregulatory strategy developmentregulatory risk assessmentauthoring complex technical documentsCTD M2 sectionsCTD M3 sectionslife cycle managementGMP regulation
Soft skills
leadershipcollaborationcommunicationdetail-orientedself-motivated
Certifications
BA/BS DegreeMS/PhD