JOB DESCRIPTION:

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 priorities
• Coordinate and execute RA strategy as per plan
• Initiate site audit with manufacturing sites
• Track Regulatory plan, submission and approval dates in internal Regulatory database in a timely manner
• Establish mitigation plan as risk arises that is aligned with cross functional team
• Communicate RA strategy, status of execution and any deviation to plan, risk and mitigation plan in monthly business reviews
• Support product impact assessment once notified of a change by the manufacturing site working closely with registration agency or distributors
• Supports vigilance activities eg adverse event reporting; field safety notification and actions
• Identify changes in the regulatory environment at an early stage and communicate it in a timely manner to the Regulatory Intelligence team for impact assessment
• Review and approve promotional materials to ensure all Regulatory requirements are met
• Plan RA budget and  report status on a monthly and quarterly update for RLBE reporting
• Engage with distributors on a regulars basis for an update on RA activities
• Establish and maintain good relationship with local laboratories, local registration agencies and distributors
• Actively participate in short and long-range planning with the Commercial team
• Promotes awareness of regulatory requirements throughout the organization
• Represents region in relevant Regulatory meetings, Regulatory in cross functional meetings an ARDx across Abbott
• Attend 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 Russia
• Experience in Belarus, CIS and Eurasian (EEU) pathway is a plus

Competencies and Attributes

• Demonstrated capacity to successfully establish and execute complex RA strategies as planned
• Capacity to identify strategic opportunities and recognize threats, and develop mitigation plans as needed
• Strong knowledge on Russia and Eurasian RA environment for IVDs
• Good understanding of Quality Management systems (ISO 13485, ISO 9001)
• Excellent written and oral communication skills in English and Russian
• Strong attention to detail and technical skills
• Strong interpersonal skills with high level of integrity, agility, collaboration and professionalism
• Ability to work in a matrix, cross functional and international environment

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

ID Infectious Disease

        

LOCATION:

Russia > Moscow : Metropolis Business Center

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

No

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable