Senior RA Specialist, Program Lead, EPNV

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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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 postapproval actions and keep regulatory and labeling databases current. You lead RA specialists and external consultants liaise with crossfunctional 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 bachelors 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

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