A global oncology biopharmaceutical company is seeking a new CMC Consultant to join their team in a Remote capacity. In this role, the CMC Consultant will be responsible for ensuring drug quality, safety, and regulatory compliance.
***This is a Remote opportunity.***
Responsibilities:
- Developing and executing CMC strategies
- Providing regulatory CMC guidance
- Supporting drug development and manufacturing
- Preparing CMC sections for regulatory submissions
- Collaborating cross-functionally with various teams
Qualifications:
- 5+ years of relevant experience
- Bachelor's Degree in a related field
- Pharmaceutical or Biotechnology degree
- Regulatory Affairs Certification preferred
- Knowledge of ICH guidelines
- Experience with cGMP regulations
- Experience in drug manufacturing
- Strong analytical skills
- Excellent communication
- Detail-oriented
Desired Skills:
- 8–12+ years of experience
- Advanced Degree
- Additional Regulatory certifications
- Lifecycle Management experience
