REGULATORY AFFAIRS LEAD UKRAINE

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.
nj.
om/.
As a Regulatory Affairs Lead Ukraine, you are part of the TURGAN cluster and report to a Regulatory Affairs Head.
You will have responsibility for full life-cycle of the products.
planning, preparation, submission, monitoring, approval, post-approval maintenance.
You will also be in charge of planning of regulatory procedures in co-operation with the Regulatory Head, Supply Chain Department, Medical Affairs, Market Access and CVTs.
This is a vital role for the organization which will help you grow your career and be part of the Johnson & Johnson mission! This role is based in Ukraine.
Key Job Activities.
Planning of the submission strategy in cooperation with Global Regulatory Affairs (GRA), IBVT, CVT and Regulatory Head Preparation of dossier for submission according to MoH requirements Execution and follow-up of all stages of registration process, starting from dossier submission up to Registration Certificate obtaining, including package materials and Package Insert leaflet preparation, technical document preparation, pharmaceutical expertise issues, communication with HA, vendors etc.
Communication with regulatory contacts in GRA for obtaining vital documents and materials, negotiations in case of any specific cases/issues.
Ensure that, where relevant local issues are identified as potentially impacting RA strategy, these are highlighted to IBVT RA, to ensure that the IBVT RA strategy can be implemented smoothly.
To make sure IBVT RA receives all local RA competitive intelligence with cross-country relevance as well as to make sure CVT gets all relevant competitive intelligence and its interpretation / impact to enable strategic decisions Ensuring optimal compliance to local, regional and Janssen regulations, to minimize risk for the patient and Janssen business Variation submission and follow up, harmonization of Instructions for medical application.
Ensure that product information is updated with the most recent variations and in accordance with CCDS and local requirements at any time.
Co-operation with CVTs and SCD in terms of new products launch planning and existing products out-of-stock prevention Co-operation with Certification & Quality Specialist in order to ensure post-registration products expertise and release Participation in the global regulatory affairs Workstreams managed by GRA Participation in the CVT/IBVT activities Act in compliance with company SOP’s and HCBI/HCC procedures (local SmPC internal approval SOP, etc) Communication with local HA, Regulatory Bodies and local pharmaceutical associations (AIPM, etc) Maintenance of the regulatory data bases and files Provision of the regulatory reporting to the GRA on the regular basis (SPS, Trackwise, WRAT, etc) Qualifications Education and Experience required Education.
Higher education or equivalent experience is required, preferably with a pharmaceutical or life sciences background.
Experience.
3+ years in a foreign pharmaceutical company.
Knowledge.
Requires expertise in general business processes execution, organizational structure of pharmaceutical company.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.