Regulatory Affairs Manager (AZ)
International Pharmaceutical Company
012 -5961868
negotiable
Job Description
To ensure that the company's products comply with all applicable regulatory requirements and industry standards, ensuring safety, quality, and legal compliance throughout the product lifecycle.
Responsibilities :
• Develop and implement regulatory strategies for new and existing products in Azerbaijan.
• Coordinate, prepare, and review regulatory submissions for pharmaceutical and medical products.
• Provide consultations and guidance to clients regarding regulatory compliance.
• Maintain current knowledge of relevant Azerbaijani and international regulations.
• Communicate with the Ministry of Health of Azerbaijan and other regulatory authorities to expedite approvals of pending regulatory-related processes.
• Manage and control regulatory documentation in accordance with local requirements.
• Review labeling, advertising, and promotional materials to ensure compliance with Azerbaijani regulations.
• Ensure compliance with regulatory standards, guidelines.
• Monitor and improve processes and procedures to maintain compliance with national regulations.
• Work closely with other departments to ensure regulatory compliance throughout the company.
• Perform other tasks assigned by the manager within the scope of competence.
Requirements :
Education
Academic or professional higher education in the fields of medicine, healthcare, pharmacy, biology, or chemistry.
Professional Experience
At least 3 years of experience in Regulatory Affairs.
REQUIRED SKILLS
• In-depth knowledge of local regulatory guidelines in Azerbaijan, with an understanding of relevant international standards.
• Strong project management and organizational skills to effectively plan, execute, and monitor regulatory projects.
• Excellent written and verbal communication skills to articulate regulatory strategies and interact with key stakeholders, including regulatory authorities.
• Ability to analyze and interpret complex regulatory information, ensuring that submissions meet all necessary requirements.
• Proficiency in at least two languages, including English and the official language(s) of Azerbaijan, to facilitate effective communication with local stakeholders and international partners.
• Strong attention to detail to ensure accuracy and completeness in all regulatory documentation.
• Ability to work collaboratively within cross-functional teams to achieve regulatory objectives.