Experienced Analyst Regulatory Affairs

hace 1 día

Ciudad de México, Ciudad de México Johnson & Johnson Innovative Medicine A tiempo completo

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Mexico City, Mexico

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at

Position summary:

This is a Regulatory Affairs professional with local/regional responsibility. The role purpose is to be responsible for the end-to-end process execution of regulatory lifecycle management (LCM) in Mexico, focused on CMC (Chemistry, Manufacturing and Controls) variations process.

Accountability: Execution of the complete LCM regulatory process related to CMC variations updates. This includes ensuring the accuracy of assessments, dossier preparation, timely submission, and securing approvals, while maintaining compliance with all relevant regulations.

Key Responsibilities:

  • Prepare submission-ready dossier based on local requirements and J&J standards and procedures.

  • Ensure assessment, submission and approval of variations in a timely manner.

  • Be first point of contact for LCM with the local Regulatory Affairs colleagues.

  • Handle any Health Authority query for LCM submissions with applicable stakeholders.

  • Continuous communication, integration and alignment with local team (i.e. RA, Supply, CQ, AW responsible, etc) of the countries in scope.

· Interactions with RMC team, Local Teams and global teams.

  • Responsible for RA databases related to LCM.

  • Archiving all relevant documents from submissions and approvals.

Qualifications

Education:

  • University degree and experience in Pharmaceutical Sciences/ Regulatory affairs.

  • Competencies

    • Strong focus on execution and compliance on submissions/approvals

    • Adaptability to adjust to regulatory changes.

    • Effective Communication.

    • Analytical and data driven decision making.

    • One team culture and Collaboration within RMC and all collaborators

    • Innovation and Continuous Improvement: skills in problem-solving, critical analysis, and the ability to identify and implement process improvements.

    • Agility and curiosity for continuous learning: Eagerness to learn and expand regulatory knowledge for other countries/clusters.

    • Accountability.

  • Experience and Skills:

    Required:

    • 3-4 years of regulatory experience in pharmaceuticals regulatory affairs area.

    • Proactive team player, able to take charge and follow-through.

    • Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.

    • Experience of working in a virtual team and/or global organization.

    • Strong in data gathering, and interpretation with proficient use of technology including RA systems.

    • Previous experience handling life cycle CMC variations.

  • Language:

    • Proficient in Spanish; intermediate/advanced English is required.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork

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