Job Description

 

  • Lead the preparation, compilation, review, and submission of high-quality regulatory dossiers (e.g., eCTD format) to relevant health authorities.

  • Manage timelines and ensure all regulatory milestones and deadlines are met.

  • Monitor, interpret, and communicate current and proposed changes in regulatory guidance, legislation, and industry standards to cross-functional teams.

  • Oversee the management of regulatory documentation and tracking systems.

  • Serve as the primary point of contact and liaison with regulatory agencies for all assigned products/projects.

  • Prepare for and participate in meetings, audits, and inspections by regulatory bodies.

  • Provide expert regulatory guidance and training to internal stakeholders, including Quality Assurance, Clinical Development, and Commercial/Marketing teams.

 


Job Requirements

  • Bachelor’s degree in  Pharmacy,

  • Minimum of 8 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.

  • In-depth knowledge of global regulatory requirements and guidelines (e.g., FDA, EMA, ICH).

  • Proven experience with regulatory submission types .

  • :Exceptional precision and meticulousness in preparing and reviewing complex technical documents.

  •  Excellent written and verbal communication skills, with the ability to articulate complex regulatory concepts clearly to technical and non-technical audiences.

  • Good in English.