Regulatory Affairs Specialist
JOB TITLE: Regulatory Affairs Specialist
EMPLOYER: PARLA Pharmaceuticals DUTY STATION: Azerbaijan
PUBLISHED: 2021-07-17 LAST UPDATED: 2021-07-17 DEADLINE: 2021-08-16

Regulatory Affairs Specialist, Baku

We provide you an opportunity to work with talented people, develop in a professional environment and realize your potential. We also hope that you will do your best with us to improve the lives of patients!

Qualifications and competencies required:

• Bachelor’s degree in Medicine, Pharmacy, Pharmacology, Chemistry etc.
• Coursework in law, marketing, business, and statistics is also appreciated;
• Strong knowledge, background, and minimum 3 years of experience for the regulatory documentation evaluation;
• Strong knowledge in local and international regulatory legislation and policies;
• Strong knowledge in Import permission requirements;
• Proficiency and familiarity with databases or other information management tools;
• Analytical skills and the ability to pay particular attention to details;

Key responsibilities:

• Carry out, manage, and maintain registration processes and necessary authority approvals of Parla Pharmaceuticals products to ensure that those are marketed in accordance and in compliance with current local legislation in Azerbaijan, and standards of the company;
• Coordinate regulatory documentation activities and processes information management, file maintenance, and coordination of tasks across multiple departments and internal stakeholders;
• Ensure compliance with local and international regulations, identify, and interpret relevant regulatory guidelines;
• Evaluate applicable laws and regulations to determine impact on company activities;
• Provide review of data or reports to the management.
• Carry out the activity of PARLA Pharmaceuticals Pharmacovigilance System and all functions related pharmacovigilance activity of company products in accordance with local requirements: SOP, PSMF, RMP, PSUR management; literature monitoring, collecting and manage of complaint reports.
• Continuous communication with local authorities and external stakeholders concerning regulatory and pharmacovigilance operations related to the company and company products;
• Obtaining Import permissions:
- Samples for registration
- In Bulk products
• Obtaining Sales permission for produced finished products.

We offer:

• Training and development opportunities within the company;
• Corporate culture and professional work environment;
• Private Health Insurance after 3 months’ probation period ;

Please send your CVs to no later than 15.08.2021.

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