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Thermo Fisher Scientific is looking for a Senior Regulatory Affairs Specialist, Russia & CIS.
Requirements:
Ability to employ your subject matter with enthusiasm to engage cross-function teams to demonstrate how the practical elements of Regulatory requirements can leverage business success in Russia and CIS
Team-orientated, self-motivated with multi-task management and problem-solving abilities
Strong communication skills with both internal and external customers, with the ability to deliver the message clearly and succinctly
Fluency in the English language
Key Responsibilities:
Deliver regulatory leadership to secure market access of new and legacy products from the portfolio
Advise colleagues on market access projects, to ensure they are planned, communicated and executed per regulatory and business requirements
Prepare, collect and review market access documents and advertising materials for the successful approval of regulatory dossiers
Conduct training and communicate appropriate materials as needed, in order to enhance knowledge of regulatory legislation in Russia & CIS region
Assist divisional regulatory departments on the update, enhancement and creation of internal policies and procedures
Identify changing regulatory legislative requirements in Russia & CIS and provide timely updates and communication of changes in the regulatory environment to key stakeholders
Be clear and communicate effectively on how the changes in regulatory legislative requirements impact the product portfolio of the business, driving functional excellence and best practice
Act as Russia & CIS point of contact to internal ad-hoc regulatory intelligence requests
Engage with regulators, when necessary, in face-to-face, oral and written communications to discuss pending or new submissions, regulatory requirements, address questions etc.
Provide input into building Russia & CIS strategy, outlining regulatory risks and opportunities
Communicate industry developments, highlighting risks/challenges the company may be facing to ensure the company remains leaders in their field of business
Maintain regulatory intelligence database for assigned territories
Build relationships with key regulatory decision-makers in industry networks
Participate and represent SDG (and other Thermo Fisher company groups as agreed), in IVD industry associations, conferences and seminars organized by state authorities involving market access process
Minimum requirements / Education:
Five years’ experience in a medical device regulatory environment
Bachelors degree or equivalent experience
Adherence to our organizational values of Integrity, intensity, Innovation and Involvement
Other skills:
Self-motivated with the ability to work independently and in a matrix environment
Good communication and interpersonal skills capable of maintaining solid working relationships
Computer literate (MS Office, Word, Excel)
What do the company offers:
Knowledge transfer with experienced colleagues
Modern home-office equipment
Performance-related salary (fixed amount & commission)
Working in an international environment
Strong team spirit
Active Career Management.
