Regulatory Lead

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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About Johnson & Johnson

At Johnson & Johnson we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal. Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at & Johnson is recruiting for a Regulatory Lead Ukraine Azerbaijan Georgia and is based in Kiev Ukraine.

Overview:

Responsibility for full life-cycle of the products: planning preparation submission monitoring approval post-approval maintenance. Planning of regulatory procedures in co-operation with Regulatory Head Supply Chain Dep. Medical Safety Quality Market Access and Country Value Teams.

Key Job Activities:

• Planning of the submission strategy in cooperation with global Regulatory colleagues and cross functional partners

• Preparation of dossier for submission according to MoH requirements

• Execution and follow-up of all stages of registration process starting from dossier submission including long term life cycle maintenance
• Preparing local submission packages technical document expertise e.g artworks prep and Module 1 documents.
• Responsible for any pharmaceutical expertise issue management communication with HA etc.
• Communication with regulatory contacts in GRA for obtaining necessary documents and materials negotiations in case of any specific cases/issues.
• Communicating timely and according to company procedures on matter relating to all registration procedures or life cycle management of the product portfolio
• Ensuring RA compliance
• Ensuring RA competitive intelligence is well review well interpreted and communicated to all stakeholders.
• Audit preparation and readiness.
• Management of local GMP recognition procedure and CoAs
• Co-operation with cross functional colleagues in terms of new products launch planning and existing products out-of-stock prevention.
• Co-operation with cross functional colleagues in order to ensure post-registration products expertise and release.
• Knowledge of Pharma GxP: Ability to work in compliance with company SOPs and HCBI/HCC procedures.
• Communication with local HA Regulatory Bodies and local pharmaceutical associations (APRAD etc)
• Maintenance of the regulatory data bases and files
• Regulatory Reporting

Qualification Requirements and Skills:

Bachelor degree or higher

Experience:

• 5 years in Regulatory Affairs in pharma preferably large multinational experience.
• Requires expertise in general business processes execution organizational structure of pharmaceutical company.
• Analytical / conceptual skills
  • Product RA legislation knowledge
  • Knowledge understanding and interpretation of legislation.
  • Awareness and ability to understand the broader picture on compliance and end to end value chain.
• Results driven and passionate to perform.
• Time management
• Ability to work within QMS and process in a large matrixed organization.
• Proficiency of business English
• PC experience: MS Word working level MS Excel - basic.
• Ukrainian language is a must.

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Preferred Skills: