Regulatory Affairs Sr Specialist

Regulatory Affairs Sr Specialist - Latam Johnson & Johnson REGULATORY AFFAIRS SR SPECIALIST - LATAM At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world. When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough. At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reinvent the way healthcare is delivered and to help people live longer, healthier lives. In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient‑centric products and solutions. We are in this for life. We are changing the trajectory of human health, YOU CAN TOO. We are searching for the best talent for Regulatory Affairs Sr Specialist to be in Latin America (Argentina or Brazil or Mexico or Colombia or Peru). Purpose : You will serve as a consultant and technical professional on documentation required for submissions for multiple business units and multiple countries in the Medical Device sector of Johnson & Johnson for LATAM markets. Major Roles and Responsibilities Actively participation and timely delivery results in RA teams to achieve common goals or attend common strategies. Prepares common registration dossiers for new product's introduction, new product development, product changes and renewals. Reviews and assesses documentation to ensure accurate interpretation of country regulations. Supervise and analyze country requirements to identify trends/changes in regulation. Consults with other partners within the organization regarding submission requirements and standards to facilitate efficient processing by health authorities in multiple countries. Serve as SME on documentation/regulation before operating companies to ensure understanding on country regulation needs. Integrates and implements results‑oriented Regulatory Affairs strategies. Accountable for the achievement of business goals and objectives, based on priorities and considering benefits/risks. Consistently leads large amounts of changing, sophisticated, and/or ambiguous information. Lead project work within team. Assists in the development of standard methodologies for Regulatory Affairs processes. Support the Strategy Lead in crafting and implementing the strategy for acquiring product registrations and supporting the lifecycle management of Medical Device products across designated Portfolio(s) in all LATAM countries. Support change assessments implementations by planning schedules for regulatory results, supervising submissions through completion. Coordinate information on several projects simultaneously. Ensures compliance with governmental regulations and interpretations. Qualifications Qualifications : Education: 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. Experience: Must have 3‑4 years of experience at least working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions for sophisticated devices and a successful track record. Desirable experience in Medical Devices, Pharma background is acceptable. Capabilities: Collaboration and teaming, Results & Performance Driven, Sense of Urgency, Integrity & Credo‑based Actions, Intellectual curiosity, Self Awareness & Flexibility, Organization and Talent Development. Knowledge Confirmed knowledge in LATAM Regulation and Processes; previous experience in dossier creation effective. Sophisticated PC skills. Analytical capability. Prioritizes work to meet deadlines. Communicates clearly, succinctly, and optimally. Planning and Organizing skills. Understands the importance of the adherence to compliance. Shown interpersonal skills including the ability to remain calm, professional, supportive, and positive. Languages: Advanced English - local language (Spanish) Type of Role: Individual contributor / Regional position. Travel %: 0-5% Reports to: RA Manager : Base location: Argentina or Brazil or Mexico or Peru or Colombia. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Sr-Principal Biostatistician - Medical Affairs (Europe and LATAM ONLY) Sr-Principal Biostatistician – Medical Affairs (Europe and LATAM ONLY)DescriptionSyneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates innovation in clinical development. This role focuses on biostatistical leadership for... 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