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Johnson & Johnson Carreiras

Regulatory Affairs Manager

Lisboa, Portugal
Regulatory Affairs


Descrição da Vaga

Requisition ID: 1805689353W

As regulatory head


Position Summary


 

The Head is responsible for the overall management of the Regulatory Affairs (RA) Department, ensuring an efficient collaboration with all Regulatory Affairs colleagues, an optimal internal and external communication and alignment with the EMEA Global Regulatory Affairs (GRA) organization and with the internal company organization.


This includes:

  • Management of the Department
  • Ensure marketing authorizations and updates are aligned with Regulatory Affairs requirements
  • Participate and cooperate with the assigned CVT, providing strategic input to meet the company objectives
  • Ensure efficient new product introduction and line extensions, including new indications
  • Maintain and support communications with Health Authorities (HA)and third parties
  • Ensure Regulatory compliance
  • Streamline Regulatory activities with other internal business partners
  • Influence Regulatory environment through external partners


Essential duties and responsibilities


Departmental management

  • Lead goals of the RA department in line with RA-EMEA & Business Goals and Objectives
  • Planning, prioritization and resources management of Regulatory activities and projects to best meet the needs of the Local Operating Company
  • Team people management, including mentoring, training, development and performance review
  • Ensure direct reports receive appropriate training in the area of expertise and functional skills
  • Provide leadership support to team members and act as a coach to the members of team
  • Represent RA at Senior Management Level
  • Ensure implementation of new systems and processes to guarantee efficiency gains and to support business continuity


New and existing products

  • Ensure preparation and submission of quality Regulatory submissions with support from Regulatory operations
  • Ensure the fulfilment of the requirements for the content management and implementation of labelling
  • Oversee the timely and efficient management of Change Controls for CCDS changes and for changes with impact on labelling
  • Oversee the performance of the activities required for the discontinuation of products
  • Provide strategic input by participating in internal working groups to meet company objectives
  • Ensure deadlines for several projects are met or raised to relevant higher management


Compliance

  • Work to implement processes, standards and trainings that ensure a continuous high Regulatory compliance level and a constant status of “inspection readiness”.
  • Ensure compliance with all Regulatory requirements (e.g. timely submission of dossiers, timely implementation and training of SOP’s & supporting systems)
  • Keep updated of the changes in Regulatory legislation/guidelines, ensuring that Regulatory Standards applicable to the LOC are monitored, evaluated (including impact assessment analysis) and timely implemented
  • Ensure timely and accurate promotional materials approval and HA notification according to local advertising legal requirements


Internal contacts

  • Handle the support to other departments based on their needs (logistic, pricing, medical, marketing, sales)
  • Coordinate the support to tender business
  • Coordinate the cooperation of the Regulatory Affairs Team to the GRA initiatives
  • Coordinate the lessons learnt and change management to ensure efficiency gains


External contacts

  • Build and sustain positive relationships with the local health authorities, in general and on product-specific topics
  • Represent the company in Regulatory industry associations in order to positively influence the Regulatory environment


Main responsibilities within CVT:

  • Ensure compliance with all legal Regulatory requirements
  • 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 Regulatory Requirements.


As external lead


Position Summary



External Lead is responsible to have a strong leading influence on main Regulatory external partners and regulations, in line with EMEA strategy, improving the possibilities of success for market access, reimbursement and lifecycle maintenance of Janssen products, for carrying out strategic discussions with health authorities and trade associations, to craft the Regulatory environment and to provide EMEA with all necessary information on local KOLs.


Essential duties and responsibilities

  • To be 100% up-to-date with all relevant developments in the Regulatory environment and translate these developments into relevant actions for the CVT and LOC RA, enabling the CVT to optimize the strategy and LOC RA to shape the RA environment and take action where needed
  • Influence and craft the external environment applying a long term strategy while focusing on and being aware of priorities and objectives (J&J, Janssen, GRPI, EMEA RA, LOC RA and sensitive issues)
  • Establishing relationships with regulators and policy-makers, bringing the Janssen opinion to the discussion / negotiating where possible
  • Be fully up to date with local and regional changes in the Regulatory environment
  • Share updates on the Regulatory environment locally and regionally
  • Providing background information to EMEA on KOLs involved in Regulatory decision-making


Job location

  • The role holder is expected to be based in the current country of residence.

Qualificações

Required education & experience:

  • University Degree in Pharmacy, Biology, Chemistry or related Life Science
  • Direct experience and strong knowledge of local/regional Regulatory requirements and guidelines
  • Solid RA legislation knowledge
  • Confirmed experience in Health Authority relationship management
  • Fluent in Portuguese and English


Skills and abilities:

  • Strong leadership, social, communication, partnership and conflict management and negotiation skills
  • External network builder
  • Excellence in communication to authorities: understanding of Regulatory legislative process and impact
  • Articulate personality, intuition, and willingness to influence and shape the external environment
  • Able to analyze complex information and situations and to formulate clear advise
  • Ability to handle multiple tasks, projects, priorities and complex systems at a time
  • Ability to work in a matrix organization and participate effectively both independatly and as part of multiple teams
  • Ability to work under strict timelines, combined with flexibility when emergency situations require this
  • Accurate and meticulous and able to make independent decision
  • People management skills
  • Project management skills
  • Knowledge of meaningful IT-systems
  • General knowledge of pharmaceutical product development
  • General understanding of business partners needs

Local Principal
Portugal-Lisboa-Lisboa
Organização
Janssen-Cilag Farmaceutica, Lda. (7290)
Cargo
Regulatory Affairs
Requisition ID
1805689353W