Керівник відділу реєстрації лікарських засобів

ФАРМА ПЕРСОНАЛ

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«ФАРМА ПЕРСОНАЛ»- спеціалізоване агентство

Regulatory Affairs Manager

LOCATION: TBILISI, GEO

Роботодавець: Грузія, Тбілісі, фармкомпанія-виробник лікарських засобів

Responsibilities: A Regulatory Affairs Manager ensures that the company adheres to the rules and regulations set by regulatory agencies and guidelines. Manages regulatory matters and executes the regulatory strategy to ensure that all necessary licensing, filings, certifications, product permits and marketing authorizations are processed and monitored. Secures timely submission of necessary documents to government agencies, ensuring compliance. Responsible for regulatory compliance in the entire process from the product development phase until the final product launch to the market. Acts as interface between the company and the regulatory authorities.

Key Responsibilities

Provide leadership in creating and executing proactive global regulatory strategies, including regulatory risk management, for product development, approval and registration, and support of future marketed products.
Accountable on the implementation the decided project registration strategy by projects planning and tracking.
Lead or coordinate both local and global team on registration plan (local team – 8 persons, plus regulatory service providers in various countries)
Lead the process for filing regulatory submissions.
Accountable on achieving the target timeline of submission and approval.
Ensure that any regulatory authorities issues are highlighted and addressed satisfactorily and in a timely fashion.
Accountable on the communication and negotiation with regulatory authorities to properly address the concerns on projects.
Accountable on the communication with local market/country teams on the related regulatory issues on the responsible projects.
Oversee post-approval commitments and monitoring and reporting of key priorities and obligations.
Review/approve of product information for packaging and package inserts, required for the approval for market entry by the authorities.
Participate in the review of promotional material to ensure compliance with regulation.
Ensure effective functioning of phamacovigilance addressing any concerns or issues.
Responsible for the quality and compliance of all pharmacovigilance deliverables.
Accountable to control project cost according to budget.

Education:

Bachelor or above with Pharmaceutical/Medical background
Fluency in English and Russian (oral and written)

Experience:

At least 4 years in drug regulatory affairs as the head of department
Successful track record interacting with the regulatory agencies, as demonstrated by timely submissions and approvals of specialty pharmaceutical/biotech compounds.
Experience in dealing with EMA and other agency liaison activities.
Experience working with R&D and commercial leadership teams.
Broad knowledge of the regulatory and competitive environment across key regions, and anticipation of future trends and impact.
The role demands a good level of computer literacy, particularly in the use of MS Office suite (Word, PowerPoint and Excel), email, intranet and simple website maintenance.

Skills & Characteristics:

Team spirit and resilience under pressure.
Proactive, creative, forward-thinker with the ability to think innovatively about integrated global strategy for regulatory.
Ability to prioritize appropriately and organize work methodically is essential.
Close attention to detail and working to deadlines.
Excellent verbal and written communication skills
Excellent organizational and planning skills
Problem solving oriented
Ability to keep information confidential
Ability to work with critical timelines.
Dynamic, self-motivated, pro-active approach to taking on challenging assignments.
High level of personal integrity

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