Regulatory Affairs & Quality Specialist – Global Impact

Grifols; Dubai; On-site; AED 120,000 - 200,000; Full time

Job summary

A global healthcare company is seeking a Regulatory Affairs and Quality Specialist to act as a link between the company and regulatory authorities in compliance with regulations. This role involves supporting approvals, resolving regulatory issues, monitoring compliance updates, and managing stakeholders. Candidates must have a Bachelor's degree in Pharmaceutical Sciences and 24 years of experience in Regulatory Affairs. A strong knowledge of regulations and excellent communication skills are essential. This is an excellent opportunity for professional growth in an international context.

Benefits

Opportunity for professional growth

Qualifications

• 24 years in Regulatory Affairs or a related field required.

Responsibilities

• Support the Scientific Office Manager in obtaining timely approvals.
• Follow up on submissions to resolve regulatory issues.
• Anticipate and respond to regulatory queries.
• Assist in closing deficiencies raised by regulatory bodies.
• Monitor regulatory updates and ensure compliance with legislation.
• Manage regulatory correspondence with authorities.
• Review product artwork and promotional materials.
• Liaise with the local Qualified Person for Pharmacovigilance.
• Support the renewal of office licenses.

Skills

Strong knowledge of regulatory requirements and compliance

Excellent communication and stakeholder management skills

Ability to work in a fast-paced international environment

Detail-oriented with strong problem-solving abilities

Education

Bachelors degree in Pharmaceutical Sciences

Job description

A global healthcare company is seeking a Regulatory Affairs and Quality Specialist to act as a link between the company and regulatory authorities in compliance with regulations. This role involves supporting approvals, resolving regulatory issues, monitoring compliance updates, and managing stakeholders. Candidates must have a Bachelor's degree in Pharmaceutical Sciences and 24 years of experience in Regulatory Affairs. A strong knowledge of regulations and excellent communication skills are essential. This is an excellent opportunity for professional growth in an international context.