Regulatory Affairs Specialist

hace 5 días

Ciudad de México, Ciudad de México Procter & Gamble A tiempo completo
Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Procter & Gamble. As a key member of our regulatory team, you will be responsible for preparing and approving submission-ready documents for renewals, variations, or rollouts, maintaining existing product licenses for medicinal products or Food Supplements, and playing an active role in the framework of dossier preparation and submissions.

Key Responsibilities
  • Plan, author, coordinate, and create all technical regulatory documents for submission to worldwide Health Authorities to secure products in the market (Module 2.3 and Module 3), or to maintain FS Master dossiers.
  • Proactively manage technical authoring and regulatory compliance activities in close collaboration with a multifunctional team such as RA (Regulatory Affairs), MPD (Development of Materials & Packaging), and QA (Quality).
  • Collaborate and guide global, multi-functional teams to ensure regulatory requirements are met to facilitate continuous improvement and support projects within complex supply chains.
  • Focus on technical authoring in the area of Base Business with flow to work to innovation on a need basis.
  • Write technical documentation in the required 'regulatory language' for submission to authorities.
  • Ensure the accuracy, completeness, and consistency of the content of the technical document and align it with the objective of the document type and classification.
  • Upload documents into the internal document management system (Veeva RIM).
  • Own the technical documentation for submission; coordinate and initiate the review & approval process and approve technical documents.
  • Be the first point of contact for questions/comments on a technical document (e.g. formatting and/or content perspective) when assigned as document owner.
  • Own technical compliance (with manufacturers information/raw data).
  • Have functional expertise and preferably appropriate external accreditation, and confirm that the content of the technical document is scientifically sound.
What We Offer
  • Responsibilities from Day 1: You will start working on key service strategies for all our organizations from the beginning.
  • Continuous coaching & mentorship: We are passionate about our work. We will ensure you receive both formal training and regular mentorship from your manager and others.
  • Multifaceted and encouraging work environment: We live our Purpose, Values, and Principles daily. We value every individual and encourage initiatives promoting agility and work/life balance.
  • Friendly and encouraging atmosphere at work.
  • Flexible work arrangements.
  • Wellness programs (anti-stress massage, yoga, nutritionist, medical checkup, daily balanced snacks).
  • Competitive salary and benefits program: private life & medical insurance for employees and dependents, PG stock, saving plans.
Job Qualifications
  • Eligibility to work in Mexico City (Interlomas).
  • 2-4 years experience with Science or Pharmacy degree.
  • Excellent English verbal and writing skills.
  • Experience in a regulatory environment in a GPS (Global Product Stewardship) or QA role.
  • Initial experience in the field of marketing authorizations/registration of Food Supplements. Knowledge about applicable Guidelines and Regulations for Medicinal products and Food Supplements in the Region Latin-America, and/or Document Management Systems would be beneficial.
  • Leadership skills – individual needs to work and negotiate in multifunctional project teams and manage multiple priorities.
  • Ability to assertively communicate risks/issues and drive action. Ability to influence and develop others.
  • Discipline, individual must be able to develop a plan, focus on priorities, manage timelines, initiate actions and execute.
  • Strong collaboration skills – individual needs to partner across functions and regions.
  • Basic communication skills in Spanish and Portuguese are beneficial.

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