Senior Analyst – CMC Biologics

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Job Description

Join a dynamic Regulatory Intelligence team and take the next step in your career in biologics regulatory affairs. We are looking for experienced professionals with strong expertise in CMC biologics, global regulatory guidelines, and regulatory submissions.

Essential Functions

• Understand and interpret global regulatory requirements for biologics, including FDA, EMA, and other international agencies.
  Support regulatory intelligence activities related to biologics submissions and product approvals.
  Analyze regulatory developments, guidelines, regulations, and laws.
  Communicate regulatory trends and requirements to internal stakeholders.
  Contribute to successful regulatory submissions and approval strategies.
  Support activities related to vaccines, biosimilars, monoclonal antibodies (mAbs), conjugate proteins, and other biological products.

Education

🔹 Required Skills

• Strong knowledge of Biologics License Applications (BLA).
  Understanding of 21 CFR Part 600 and ICH Q5A–E guidelines.
  Expertise in global biologics regulatory requirements.
  Ability to interpret and communicate regulatory changes effectively.
  Proven experience in regulatory submissions and product approvals.
  Excellent analytical, documentation, and communication skills.

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