Senior Regulatory Affairs specialist/ Старший специалист по регуляторным вопросам

We are looking for Senior Regulatory Affairs specialist to join the Medical device group in RA department

Responsibilities:

• Prepare of registration dossier, responses on Agency DQs, etc., manage submissions and approvals for the assigned products marketed and/or registered in RU/EAEU&CIS (when applicable) or new products intended to be marketed in RU/EAEU &CIS (when applicable);
• Coordinate labeling updates for assigned products;
• Assist with change management assessment for the assigned products;
• Maintain existing product marketing authorizations and gain Regulatory approval of variations;
• Gather a thorough knowledge of the registration files and all related company product documentation. Keep up to date on Company products;
• Support implementing a regulatory strategy for the company portfolio according to the National legislation and EAEU legislation;
• Review and prepare dossiers and/or other documents for signing prior to submission;
• Review Product Information in accordance with legal and regulatory requirements;
• Participate in packaging projects implementation within agreed timeframe, including, when needed, development with third parties of updated artwork for cartons, labels and instructions in accordance with Company requirements and local regulations;
• Create and update paper/electronic archives of certificates and dossiers;
• Maintain actual status for all submission plans, submissions and approvals in AbbVie RA electronic systems;
• Ensure that all prescribing information/Instruction for use is accurate and updated in accordance with Company policies and local regulations;
• Provide timely and accurate updates to relevant internals stakeholders on regulatory submissions and approvals, in accordance with company SOPs/policies;
• Track samples/standards import, coordination of laboratory/clinics activities if needed;
• Participate in Local brand-teams for assigned products and providing regulatory support for Commercial and Sales force;
• Review promotional, non-promotional materials per agreed guidelines & within required timeframe;
• Assist in development and updating local standard operational procedures.

Requirements:

• University degree in Equipment Engineering/Pharmacy or Life/Natural Sciences;
• Minimum of 3 years’ Regulatory Affairs experience in an associated company within the Healthcare Industry. Experience in registration of high risk class devices (2b,3, implantable) is an advantage;
• Adequate judgment, strong communication and negotiating skills;
• Teamwork skills;
• Comprehensive knowledge of local (national and EAEU) Regulatory Affairs requirements;
• Able to work with big volumes of documents and texts;
• Attentive to details, responsible and well-organized;
• Intermediate in English both verbal and written;
• Good presentation skills;
• Efficient computer skills.

Conditions:

• Comfortable office in the center of Moscow (hybrid work format);
• Medical insurance, meal and mobile allowance, annual bonus;
• The possibility of professional and career development.