Senior Regulatory Affairs Specialist

An international pharmaceutical company has opened a competition for the position of Senior Regulatory Affairs Specialist

Responsibilities:

• Planning and managing EAEU/RU national regulatory submissions of medicinal products (MP) and food supplement registration process according to the company business plan and in accordance with EAEU/RU regulatory requirements;
• Involved in the process of creating the strategies for registration and maintenance of MP in EAEU/RU;
• Preparation of dossiers, assessment of documents for compliance with the requirements of the RF and EAEU during initial MA registration, renewals and variations ensuring that all stages of expertise are completed accordingly; 
• Preparation of dossiers, assessment of documents for compliance with the requirements of the EAEU for food supplement; 
• Managing of food supplement certification;
• Communication with Competent Regulatory Authority during initial MA, renewal and variation procedures
• Coordinating Letters of Deficiency for initial MA, Variations and Renewals for EAEU/RU national procedures; review and modification of responses to the Competent Regulatory Authority requests for all procedures; preparing responses to Regulatory Authorities requests
• Preparing administrative documents (AF, CL and other additional country specific documents)  for EAEU/RU national procedures during initial MA, renewals and variations of the marketing authorization in compliance with EAEU/RU regulatory requirements and in cooperation with Head Quarters (HQ) in strict timelines
• Developing ND, SmPC, PIL in accordance with RU and EAEU requirements;
• Involving in the process of developing of the labelling and product packaging Artworks for MP in local language and food supplement;
• Checking and confirmation of the Product Information standards (including transport and pallet labels);
• Following and evaluation of EAEU/RU national legislative on day to day basis and communicating it with Regulatory Affairs in HQ; 
• Maintaining high level of awareness in Russian and EAEU Regulatory legislative;
• Daily planning and tracking in internal RA database; 
• Organizing the supply of finished product samples required as mandatory part of the registration procedures (initial MA and variations) and if needed - preparation of documentation and receiving for import permits;
• Preparing appropriate documentation and submitting registration samples to the approved laboratories for expertise of products;
• Submission and monitoring of the authorization process till successful completion;
• Review and modification (Head Quarters should be consulted) of responses to the Competent Regulatory Authority requests for national procedures ;
• Screen Marketing Authorization (registration certificates), Variation approvals and approved Product Information for errors and ensure successful correction;
• Checking of final word version in accordance with last approved PI and maintaining internal database;
• Reviewing, signing and final approval of the Product information standards (including transport and pallet labels), including Braille reads (Mock up and PIL) for commercial production (to be implemented step by step) for medicine products and food supplements;
• Coordination and submission of documents to the State Institute of Drugs and Good Practices (Ministry of Trade and Industry) of Russian Federation in order to organize GMP inspection and with the view of obtaining national/EAEU GMP certificate; 
• Share and exchange the knowledge with HQ staff gained from trainings
• Mentorship of new employees and transferred associates with regulatory related tasks;
• Serialization monitoring for national /EAEU requirements.

Requirements:

• University degree in pharmaceutical sciences;
• English language - upper-intermediate;
• Good knowledge and understanding of local legislation in regulatory sphere;
• Experience in generic company (preferable);
• Experience of working in Regulatory Affairs - at least 3 years;
• Strategic thinking.

Benefits:

• Fixed salary (based on interview results);
• Annual bonus;
• Compensation for food;
• Competitive salary and bonus system;
• Medical and life insurance.