Position Title: RUBYCIS Commercial RA Manager

Overview

The Abbott Rapid Diagnostics Infectious Disease Business Unit, is looking for an experienced, dynamic and talented Commercial Regulatory Manager to lead and drive Regulatory activities for the Abbott portfolio distributed in the Russia, Belarus and CIS region (RUBYCIS).

Job purpose

The RUBYCIS Commercial RA Manager will be responsible for all Regulatory related activities in Russia, Belarus and CIS countries, including but not limited to product registration, product changes, review of promotional materials, Field Safety Notice and Action, identifying changes in regulation, planning transition to Eurasian regulation, update to internal RA database, engagement with industry association

Responsibilities

Establish RA strategy in collaboration with local registration agencies or distributors,  manufacturing sites, Marketing, Supply Chain and Finance aligned with Commercial prioritiesCoordinate and execute RA strategy as per planInitiate site audit with manufacturing sitesTrack Regulatory plan, submission and approval dates in internal Regulatory database in a timely mannerEstablish mitigation plan as risk arises that is aligned with cross functional teamCommunicate RA strategy, status of execution and any deviation to plan, risk and mitigation plan in monthly business reviewsSupport product impact assessment once notified of a change by the manufacturing site working closely with registration agency or distributorsSupports vigilance activities eg adverse event reporting; field safety notification and actionsIdentify changes in the regulatory environment at an early stage and communicate it in a timely manner to the Regulatory Intelligence team for impact assessmentReview and approve promotional materials to ensure all Regulatory requirements are metPlan RA budget and  report status on a monthly and quarterly update for RLBE reportingEngage with distributors on a regulars basis for an update on RA activitiesEstablish and maintain good relationship with local laboratories, local registration agencies and distributorsActively participate in short and long-range planning with the Commercial teamPromotes awareness of regulatory requirements throughout the organizationRepresents region in relevant Regulatory meetings, Regulatory in cross functional meetings an ARDx across AbbottAttend relevant Industry forums

Reporting to

Commercial RA Associate Director EMEA (solid)Commercial Head Russia/Belarus (dotted)Commercial Head CIS (dotted)

Qualifications

Essential

BSc or equivalent.A minimum of 8 years in Regulatory Affairs in RussiaExperience in Belarus, CIS and Eurasian (EEU) pathway is a plus

Competencies and Attributes

Demonstrated capacity to successfully establish and execute complex RA strategies as plannedCapacity to identify strategic opportunities and recognize threats, and develop mitigation plans as neededStrong knowledge on Russia and Eurasian RA environment for IVDsGood understanding of Quality Management systems (ISO 13485, ISO 9001)Excellent written and oral communication skills in English and RussianStrong attention to detail and technical skillsStrong interpersonal skills with high level of integrity, agility, collaboration and professionalismAbility to work in a matrix, cross functional and international environment