Regulatory Manager

Industry:

About the Company:

nationwide.

Working Days & Hours

• Working Days:

  Monday to Saturday (2nd & 3rd Saturdays Off)
  

• Working Hours:

  10:00 AM to 7:00 PM

Job Title:

Key Responsibilities

• Regulatory Expertise:

  Oversee regulatory processes for pharmaceutical finished formulations across CIS, LATAM, and Africa regions.

• Dossier Management:

  Compile and review ACTD and CTD dossiers to ensure accuracy, compliance, and timely submissions.

• MOH Query Response:

  Address and resolve Ministry of Health (MOH) queries for submitted dossiers within deadlines.

• Compliance Oversight:

  Review product artworks, labels, and samples for adherence to regulatory guidelines.

• International Coordination:

  Communicate and coordinate with international agents for dossier submissions, follow-ups, and product registrations.

• Documentation Management:

  Maintain thorough records of technical documents, product registrations, and related expenses.

• Team Management:

  Lead, mentor, and supervise the Regulatory Affairs team to meet regulatory objectives and submission deadlines.

Requirements

• Proven expertise in regulatory affairs for pharmaceutical finished formulations in CIS, LATAM, and Africa.
  
• Strong experience in compiling and reviewing ACTD and CTD dossiers.
  
• Proficiency in addressing MOH queries and ensuring timely resolutions.
  
• Exceptional attention to detail for reviewing product artworks and samples.
  
• Excellent coordination skills for managing international agent communications and submission processes.
  
• Solid organizational abilities for maintaining comprehensive technical documentation and expense records.
  
• Leadership experience in managing and developing high-performing regulatory affairs teams.
  

Preferred Qualifications

• Bachelors or Masters degree in Pharmacy, Regulatory Affairs, or a related discipline.
  
• Minimum

  10+ years of relevant experience

  in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of international regulatory frameworks for CIS, LATAM, and Africa markets.
  
• Strong communication, interpersonal, and coordination skills, especially with cross-functional teams and global agents.