Regulatory Affairs

Premium Solutions Consultancy; Doha; On-site; QAR 200,000 - 400,000; Full time

Job summary

An established industry player is looking for a dedicated Regulatory Affairs Specialist to ensure compliance with regulatory requirements for various client projects. This role involves preparing and submitting regulatory applications, maintaining product registrations, and collaborating with cross-functional teams to develop effective regulatory strategies. The ideal candidate will have a strong background in regulatory affairs, excellent communication skills, and a keen attention to detail. Join a dynamic team where your expertise will directly impact the success of innovative products in the healthcare sector.

Qualifications

• 3+ years of experience in regulatory affairs within pharmaceuticals or biotechnology.
• Strong knowledge of local and international regulations.

Responsibilities

• Prepare and submit regulatory applications and maintain product registrations.
• Monitor regulatory changes and communicate impacts to clients.

Skills

Regulatory Compliance

Project Management

Communication Skills

Analytical Skills

Attention to Detail

Education

Bachelor's degree in a scientific or healthcare-related field

Job description

Premium Solutions Consultancy is seeking a highly skilled and motivated Regulatory Affairs professional to join our team. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our client projects. You will work closely with cross-functional teams to prepare and submit regulatory applications, maintain product registrations, and monitor regulatory changes.

Responsibilities

• Prepare and submit regulatory applications, including product registrations and notifications
• Coordinate with internal and external stakeholders to collect necessary documentation and information
• Maintain up-to-date knowledge of relevant regulations and guidelines
• Monitor and communicate changes in regulatory requirements that may impact our clients
• Conduct regulatory assessments for new products and ensure compliance throughout the product lifecycle
• Participate in regulatory agency inspections and audits
• Collaborate with cross-functional teams to develop regulatory strategies and plans
• Review and provide input on labeling and promotional materials to ensure compliance

Requirements

• Bachelor's degree in a scientific or healthcare-related field
• Minimum of 3 years of experience in regulatory affairs in the pharmaceutical, medical device, or biotechnology industry
• Strong knowledge of local and international regulatory requirements and guidelines
• Excellent communication and project management skills
• Experience in preparing and submitting regulatory applications
• Attention to detail and strong analytical skills
• Ability to work independently and in a team environment