Вакансія Regulatory Manage/Coordinator of MPI Projects

What we're looking for:

• University Degree in Pharmacy, Chemistry/Biology;
• Preferably at least 3 years of Regulatory experience in an associated company within Health Care Industry;
• Fluency in English;
• Efficient Computer Skills;
• Excellent communication and interpersonal skills.

Job Responsibilities

• According to Regulatory Plan and according to the decisions taken in the strategy, request and follow-up the receipt of Registration dossiers from ERO, on time;
• Review the data originating from ERO or from any other Abbott Affiliate and coordinate and obtain all the certificates and documents necessary for applications;
• Prepare local language files (chemical and pharmaceutical; pre-clinical and clinical parts) for the registration applications of new products, according to the Registration Dossier Preparation SOP;
• Prepare re-registration applications in order to maintain the registration of marketed products;
• Obtain MOH samples and reference standards for the registration purposes;
• Ensure product registration is completed to support NPI timelines;
• Make price analyses; inform marketing and finance departments and coordinate the determination of FOB and retail prices of the products to be registered and already registered;
• Obtain pricing information and price certificates from relevant countries for marketed products;
• Submit pricing information to MOH, according to the Pricing SOP;
• Ensure package insert is routed to Medical Department for approval before MOH submission;
• Follow up MOH approval and open Yellow Folder at AI Regulatory based on additional requirements which are requested;
• When approved by MOH, update artwork, give approval for printing and coordinate with TPM and/or manufacturing site;
• Develop the artwork for new submission according to AI labeling standards;
• Finalize approval procedure of the artwork for new submission between RA and Marketing Departments;
• Review and approve promotional materials which are prepared by Marketing Department from regulatory point of view;
• Prepare and assist Administrative Assistant for sending necessary information to the reimbursement organizations for the marketed products;
• Prepare and submit necessary information for the new registered products to the reimbursement organizations.

What We Offer

• Pleasant working atmosphere and manifold corporate and social life;
• Professional and career growth promotion, which depends on your will;
• Professional development opportunities, which is a part of global company politics and culture.