Regional Regulatory Affairs Senior Manager- Janssen
Johnson & Johnson
Bogotá, Colombia
hace 7 días

ABOUT J&J :

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science -

bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

We have more than 275 operating companies in more than 60 countries employing approximately 128,700 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

Our Family of Companies comprises :

  • The world’s sixth-largest consumer health company
  • The world’s largest and most diverse medical devices and diagnostics company
  • The world’s fifth-largest biologics company
  • And the world’s eighth-largest pharmaceuticals company
  • Regional Regulatory Affairs Senior Manager- Janssen

    The Regional Regulatory Leader LA, Associate Director / Sr. Manager is a member of the Global Regulatory Affairs organization.

    The position resides in the LA region and is responsible for working with the local regulatory affairs departments, Global Regulatory Team and head office-

    based team members to define and implement the regional strategy for assigned products. The position is accountable for leading and providing region or country input into the global regulatory strategy to global regulatory teams for established products.

    This position is a contributor of the regional team focused on delisting and new business opportunities by providing regulatory inputs.

    The position is responsible for consolidation of strategy and prioritization of of countries aligned with business and R&D objectives.

  • The position also ensures product variations, including labeling changes, supplements, and amendments; Product License Renewals and providing regional affiliates with timely responses to Health Authority enquiries;
  • as well as regulatory support to all affiliates in the region for the pharmaceutical sector business. This support includes J&J global products as well as licences products (global, regional, local) and regional / local developed products.

    Some of these activities will be performed in alignment with the regional Management center focused on life cycle management of products.

    The Center is embedded in the AP, EMEA and LA regional organizations, and it will work in close collaboration with the respective LOCs and regional and global departments.

    The RMC Manager drives integrated local RA planning on regional scope to eneble RMC to achieve deliverables with optimal resourcing.

    He or she is responsible for the set-up and maintenance of the rolling RMC resource planning and integrating submission planning form global, regional and local RA.

    The incumbent will be accountable to engage stakeholders throughout the process to define best fit planning and assign submissions to RMC staff and monitor progress.

    Other responsibilities : He / she is an active member of the regional NBO team. To ensure consolidation of strategy and prioritization of countries aligned with business and R&D objectives.

  • Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area. Participates as a standing member of the project related GRT Established Products;
  • supports the GRT by providing strategic regional input into compound development, registration and life cycle management.

    Sr. Manager / Associte Director would support regional Director in complex projects. Provides input in post-registration activities, including labeling changes.

    Provide regional implementation and regulatory-based advice on new and updated Core Data Sheets. Co-develop and optimize RMC planning tool.

    Embeds the planning process in the region. Collect input from involved Global, Regional, Local regulatory teams. Drive integrated planning process by engaging RA stakeholders to ensure insight on all inputs.

    Identifies gaps / areas for clarification (with CMC & Global labeling, LOC, RMC team members). Take action to close these gaps in liaison with Global, Regional, Local and RMC regulatory teams.

    Monitor resource planning and pro-actively act on potential conflicts. Co-create the LOC management report (dashboard). Responsible for Quality related tasks.

    Contribute to standardization / new systems (eg. Intagrass, Insight) and RMC systems (eg. Planning tool, recipe book) and processes to ensure efficiency gains.

    Review reports received from the GLCoE and CMC reports in order to correct and analyze reasons for non-compliance and sends feedback to the compliance teams in order to improve the overall compliance.

    Responsible for internal RMC training gaps and refreseher trainings as well as assuring the training of internal newcomers and assure appropriate number of trained back up staff.

    Single point of contact for the CMC variations asuring common understanding of the variations and execution of the submissions.

    Determines timing and strategy for meeting with regulatory agencies in LA, and leads preparations for these meetings along with relevant regulatory and compound development team members and regional regulatory staff.

    Prepares global company personnel for interactions with HAs in LA Provides guidance to local operating companies to determine timing and strategy for regional HA meetings.

    Participates in preparations for interactions with HAs and assist operating company with these interactions. Serves as point of contact with local operating companies Ensures excellent collaborative relationship with key stakeholders including staff in the region and R&D partners.

    Interacts with local operating companies on individual products / processes Facilitates discussions with local operating companies on regional or global regulatory issues, as required Acts as the primary contact with multifunctional regional teams such as regional marketing, Alliance logistics and supply chain and trademark office in US.

    Advises the GRT, and as needed, CDT and R&D functional representatives, on required documents and processes to support HA contacts and submissions.

    Provides input to submission tactical planning and timelines including lifecycle submissions (labeling changes, renewals and safety reports).

    Coordinates and follows-up on post-approval submissions to ensure that product remains in compliance Reviews and provides input to critical submission documents.

    Delivers on business critical regulatory submissions in accordance with development and / or post marketing priorities and timelines.

    Participates in Rapid Response Teams to ensure appropriate and timely responses to HA questions. Provides clarification regarding HA questions and provides input to the strategy for responding to HA questions.

    Ensures tracking of submission and approval milestones. Provides coaching and guidance to local affiliates regulatory staff as appropriate.

    Provides support to training activities to new hires on global and regional processes. Responsible for the management of regional in-

    licensed registration submissions, including drafting of the license agreement draft (regulatory aspect). Participates in the development of department processes and procedures.

    Ensures that defined processes are developed and implemented within the regional regulatory office to track and communicate key regulatory product activities (including CCDS changes) and milestones.

    Updates HQ regulatory staff regarding changes in regional regulatory requirements and seeks to shape a favorable regulatory environment through networking with Industry Group.

    Provides support to the implementation of global, regional and local processes.

    Qualifications

  • Professional degree, preferable in Health Care areas;
  • Post graduation degree or MBA will be considered a plus;
  • Languages : Fluent in English is a requirement and either Spanish or Portuguese fluency;
  • Previous experience in Healthcare industry will be considered a plus;
  • Good understanding of the pharmaceutical industry;
  • Detailed knowledge of local laws, regulations and guidances in the region related to full drug life cycle;
  • Understanding of how laws, regulations and guidances apply to specific projects. Ability to interpret them and understand them in the context of the scientific and commercial environment;
  • Good understanding of drug global development and / or marketed products;
  • Ability to anticipate and influence regulatory developments in the region and assess business impact;
  • Understanding of the scientific and medical principles applicable to the therapeutic area and specific products;
  • Awareness of pricing and reimbursement issues in LA;
  • Understanding of how supply chain decisions impact registrations in LA;
  • HA and Operating Company Interactions;
  • Detailed knowledge of HA structures, how those agencies operate, and how and when to interact with them to generate a successful outcome;
  • Ability to work with and influence HA actions and outcomes;
  • Project-related knowledge of commercial / medical business needs;
  • Broad understanding of scientific data (CMC, clinical and non-clinical);
  • Comprehensive understanding of the needs of global teams and regional business partners;
  • Detailed knowledge of laws, regulations, and guidances as they apply to submissions in the region;
  • Knowledge of what is needed for dossier components and submissions, how to obtain regional components and how long it will take to gather it;
  • Understanding of documentation requirements;
  • Ability to analyze reports to determine whether they meet regulatory requirements, and are consistent with the regulatory strategy;
  • Knowledge of local labeling requirements;
  • Ability to critically review labeling development / labeling revisions and assess impact on relevant countries;
  • Knowledge of competitive landscape and how other companies are dealing with similar issues in labeling;
  • Experience in labeling negotiations with health authorities.
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