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**Job Function: **
Regulatory Affairs Group
**Job Sub Function: **
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Buenos Aires, Argentina
Job Description:
**Job Summary **
As Country Regulatory Affairs Lead, you coordinate regulatory activities across assigned markets, define and implement strategies for NPIs and LCM, manage submissions and post‑approval actions, and keep regulatory and labeling databases current. You lead RA specialists and external consultants, liaise with cross‑functional teams and franchises, represent J&J to health authorities, and monitor regulatory changes to ensure compliant, timely product approvals.
Major Roles and Responsibilities
Coordinate the regulatory activities in the country (or group of countries) under scope.
Determine regulatory strategy for NPIs (New Products Introduction) and LCM (Life Cycle Management).
Execute submissions for new registrations, changes and renewals.
Drive post approval activities
Liaise with cross-functional partners
Coordinate the work of RA specialists to ensure flowless business plan execution.
Select and manage external consulting services to prepare files as needed.
Supports regional team on product submissions schedules, prioritization and pipeline management.
Act as liaison for franchises to support business plans and regulatory needs.
Prepare and lead training for RA Specialists
Propose innovative strategies/solutions for technical files and submission to fulfill requirements and follow regulatory agency requirements.
Participate in multifunctional teams to establish regulatory strategic plans with minimal guidance.
Assist in the development and implementation of regulatory strategies with team representatives and with the Regulatory Affairs Manager.
Prepare alert communications according to registration process progress and findings during this
Lead specific projects/requests to ensure alignment with business goals and timely responses.
Coordinate information on several projects simultaneously.
Interacts with other stakeholders, government agencies in a professional, decisive, & articulate manner.
Scan and influence the external environment.
Represent J&J at Local MoH meetings and external organizations.
Provide assistance with establishment registration licenses.
Coordinate/assist in the review and analysis of market licenses and labeling to set up product codes status.
Ensure that Regulatory Databases and Labeling Databases are well updated as per submissions and approvals received
Identify and communicate new regulatory/legal requirements
Support franchise, bids and functional areas consultations to clarify regulatory questions/conditions.
Competencies
knowledge of Local & International Regulation and Processes
Analytical capability
Solid Problem Solving - sorting through ambiguity to design solution plans; creative and compliant solutions to day-to-day issues
Prioritizes work to meet deadlines
Communicates clearly, succinctly and effectively.
Planning and Organizing skills
Understands the importance of the adherence to compliance
Solid interpersonal skills include the ability to remain calm, professional, diplomatic, and positive.
Experience Requirements
- Must have 4 years’ experience working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions for complex devices and a successful track record. Desirable experience in Medical Devices and Pharma background is acceptable.
- A bachelor’s degree in engineering, Pharmacy or other life science: Can be a person with related experience and/or training or equivalent combination of education and experience. Advanced Degree preferred.
- Fluent English.
- Advanced PC skills
**Required Skills: **
Preferred Skills:
Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking