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Senior Regulatory Affairs Specia...

Bluebell Pharmaceuticals...
Maadi, Cairo
Bluebell Pharmaceuticals  logo

Senior Regulatory Affairs Specialist

Maadi, CairoPosted 1 month ago
42Applicants for1 open position
  • 19Viewed
  • 10In Consideration
  • 5Not Selected

Job Details

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Job Description

Develop and implement regulatory strategies for new product development and lifecycle management.
• Prepare, review, and submit regulatory dossiers (CTD/eCTD format) for FDA, EMA, and other global regulatory authorities.
• Coordinate and manage communications and responses to regulatory agencies.
• Monitor and interpret global regulatory changes and assess the impact on the company’s products and processes.
• Support labeling, advertising, and promotional material review to ensure compliance with regulations.
• Represent Regulatory Affairs on cross-functional project teams and guide regulatory requirements.
• Maintain regulatory documentation and databases by internal SOPs and external requirements.
• Provide mentorship and guidance to junior regulatory staff.
• Participate in audits and inspections as the regulatory representative.

Job Requirements

Bachelor’s degree in pharmacy, Sciences, Chemistry, or a related field.
• 5–7 years of experience in Regulatory Affairs within the Neutraceutical or Cosmeceuticals industry.
• Proven experience in preparing regulatory submissions (IND, NDA, ANDA, MAA).
• Strong knowledge of FDA, EMA, ICH guidelines, and global regulatory requirements.
• Experience working with cross-functional teams in a regulated environment.
• Excellent written and verbal communication skills.
• Detail-oriented with strong organizational and project management abilities.
 

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