Johnson & Johnson Carreiras

Regulatory Affairs Expert

Lisboa, Portugal
Regulatory Affairs


Descrição da Vaga

Requisition ID: 1805674672W

Position summary
Under supervision of the Head, the Regulatory Affairs Expert is responsible for the regulatory activities to support and grow the business aligned with the company goals. This includes:

Obtain and maintain marketing authorizations
Participate and support the assigned CVT, providing strategic input to meet
        company objectives
Ensure introduction of new products and line extensions
Maintain and support communications with Health Authorities and third                parties
Ensure regulatory compliance
Streamline regulatory activities with other internal business partners
Influence regulatory environment through external partners

Essential Duties and Responsibilities

New and existing products
Prepare and submit regulatory applications with support from Global                    Regulatory Team
Translate and review all labelling documents
Provide strategic input by participating in internal working groups to meet            company objectives
Ensure that deadlines for several projects are met or raised to the Head of          RA
Maintain the product label and packaging in line with current registered                authorization details according to the relevant local and EU legislation
Oversee the process of development and implementation of the packaging          materials

Compliance

Support compliance with all regulatory requirements (e.g. timely                          submission of dossiers, timely implementation and training of SOP’s &                supporting systems)
Maintain an awareness of regulatory guidelines/directives/national                        requirements in order to provide appropriate advice
Act as a Regulatory Compliance Representative, ensuring that Regulatory          Standards applicable to the Local Operating Company are monitored,                  evaluated (including impact assessment analysis) and timely implemented
Prepare and maintain local documents
Timely and accurate promotional materials approval and proceed to the              Health Authorities notification according to local advertising legal                          requirements
Collaborate on the management of Deviation, CAPA, Change Control and          Risk Assessment activities
Prepare and participate on the Internal Audits related to regulatory                      activities
Provide input on the identification and accomplishment of quality                          objectives related with regulatory activities (Quality Planning)
Assure accomplishment of the all the trainings as defined on the Individual          Training Plan
Assist in aspects related with Quality System, namely supporting the                    improvement of quality system, evaluate quality indicators and trend                    reports
As Records Coordinator, ensure an effective management of the                          regulatory  and quality affairs records and that all the information is duly              archived throughout the period that is needed; provide input to update and          improve the RRS, from the Regulatory and Quality perspective

Main responsibilities within Country Value Teams (CVTs):


Review promotional materials according to the CVT product strategy
Timely labelling sharing and monitoring
Ensure compliance with corporate/legal requirements for                                      Corporate/External Affairs and MSL materials
Ensure fast introduction of new products and line extensions according to            business priorities, providing input and supporting all available procedures          (e.g. special use authorizations, standard export packs, shared artworks)
Provide timely regulatory product updates regarding MA variations that                impact business goals
Provide strategic and timely input concerning competitors landscape to                allow anticipate reactive actions (launches, patents, generics, new                      indications/formulations)
Provide timely and accurate consultation, interpretation and advice to                  CVTs regarding regulatory environment
Ensure awareness of all CVT members on the relevant Regulators
        Requirements, and Ensure compliance with all legal regulatory requirement

Required education & experience
University Degree in Pharmacy, Biology, Chemistry or related Life Science
Regulatory Affairs experience at both operational and strategic level
Direct experience and strong knowledge of general regulatory                              requirements and guidelines
Fluent in local language and English

Skills and Abilities
Strong social, communication, partnership and negotiation skills
Ability to run multiple tasks, projects, priorities, and complex systems                  simultaneously
Ability to work in a matrix organization and participate effectively both                  independently and as part of multiple teams
Ability to work under strict timelines, combined with flexibility when                      emergency situations require this
Project management skills
Knowledge of relevant IT-systems
Basic understanding of pharmaceutical product development
General understanding of business partners need



Qualificações

   REQUIRED EDUCATION & EXPERIENCE  


University Degree in Pharmacy, Biology, Chemistry or related Life                  Science

Regulatory Affairs experience at both operational and strategic level

Direct experience and strong knowledge of general regulatory                      requirements and guidelines

Fluent in local language and English



        SKILLS AND ABILITIES 


Strong interpersonal, communication, teamwork and negotiation skills

Ability to manage multiple tasks,  projects, priorities,and complex                  systems simultaneously

Ability to work in a matrix organization and participate effectively both            independently and as part of multiple teams

Ability to work under strict timelines, combined with flexibility when                emergency situations require this

Project management skills

Knowledge of relevant IT-systems

Basic understanding of pharmaceutical product development

General understanding of business partners need



Local Principal
Portugal-Lisboa-Lisboa
Organização
Janssen-Cilag Farmaceutica, Lda. (7290)
Cargo
Regulatory Affairs
Requisition ID
1805674672W