Regulatory Affairs Executive

Position Summary:

The Executive Regulatory Affairs (Biosimilars) will be responsible for the preparation, review, and submission of high-quality CMC documentation to support regulatory filings in the US, Europe, and other global markets. The role involves cross-functional collaboration, drafting of eCTD modules, and ensuring compliance with international regulatory requirements for biosimilar products.

Role & responsibilities

• Review and finalize

  CMC (Chemistry, Manufacturing, and Controls)

  documents for

  US (FDA)

  and

  European (EMA)

  regulatory submissions.

• Draft, compile, and review eCTD sections

  , ensuring compliance with current regulatory and technical standards.

• Author and review key regulatory documents

  , including

  INDs, IMPDs, and Briefing Books (BBs)

  .
• Collaborate effectively with

  cross-functional teams (CFTs)

  such as Quality, Manufacturing, Analytical, and Clinical to gather required information and align on submission strategy.
• Ensure the use of

  appropriate regulatory language

  and consistency across all submission documents.
• Ensure documents meet

  PDF publishing and technical property requirements

  for eCTD submissions.
• Maintain up-to-date knowledge of

  ICH guidelines

  ,

  regional regulatory frameworks

  , and

  biosimilar-specific requirements

  .
• Support

  regulatory strategy development

  and

  responses to health authority queries

  as needed

Qualifications and Experience:

• Masters degree

  in Pharmacy, Biotechnology, Life Sciences, or a related discipline.
• Minimum

  3

  years of experience

  in

  CMC regulatory affairs

  with a focus on

  biosimilars

  .
• Hands-on experience with

  IND, IMPD, and eCTD submissions

  .
• Strong understanding of

  ICH and regional regulatory requirements

  for biosimilar development and registration.
• Proficiency with

  electronic publishing tools and eCTD document standards

  .
• Excellent

  communication, coordination, and documentation skills

  .
• Strong attention to detail, regulatory writing, and analytical skills.