Senior CMC Regulatory Affairs Consultant (Small Molecule or Biologics)

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.)

Desirable Skills:

• 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.