Senior CMC Regulatory Affairs Consultant (Small Molecule or Biologics)
Parexel International Corporation
USA - Any Region - Home Based
Parexel's Regulatory Consulting team continues to grow! We are currently looking for experienced CMC Small Molecule or Biologics Regulatory Affairs professionals who are passionate about drug development and committed to making a difference!
As a Senior CMC Consultant, you will be responsible for:
Authoring CMC maintenance documentation for pre and post approval submissions
Briefing documents for HA meetings & scientific advice
Communicating with regulatory authorities
Participating in scientific advice meetings
Preparing responses to HA questions on pre and post-approval activities
Devising global regulatory strategy for post-approval submissions
Providing strategic regulatory advice in regards to pre- and post-marketing issues to clients
Conducting due diligence and gap analysis of existing products, and advising on remediation activities
Preparing and submitting applications for marketing authorizations and variations for human medicinal products
Supervising development and technology transfer projects from a regulatory affairs perspective
Providing CMC input to clinical modules (bioanalytical method validation, extrapolation report, etc.)
• High-level consulting skills
• Critical thinking and problem-solving skills
• Project leadership and management knowledge
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Client-focused approach to work
• Results orientation
• Teamwork and collaboration skills
QualificationsMinimum of a Bachelor’s Degree, Advanced Degree preferable in Biochemistry, Biotechnology, Molecular- or Cell Biology, or have comparable experience in research
10+ years relevant experience in the pharmaceutical industry in roles such as Product Development, Manufacturing, Quality or Regulatory Affairs.
Knowledge in molecular and cell biology
A deep understanding of molecular biological and (bio-)chemical methods
Extensive experience in preparing documentation for regulatory authorities.
Previous experience with a regulatory agency (such as FDA, MHRA) is a plusEEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.