Regulatory Lead

Johnson & Johnson • Full-time • UA001 Kyiv, Ukraine • 1w ago

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 https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Kyiv, Kyivska oblast, Ukraine

Job Description:

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 https://www.jnj.com/.

Johnson & 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 SOP’s 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.

Required Skills:

Preferred Skills: