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Regulatory Affairs Specialist
hace 2 meses
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Procter & Gamble Mexico. As a key member of our regulatory team, you will be responsible for preparing and approving submission-ready documents for renewals, variations, or rollouts of medicinal products and food supplements.
Key Responsibilities- Prepare and maintain existing products licenses for medicinal products and food supplements.
- Plan, coordinate, and create all technical regulatory documents for submission to worldwide health authorities.
- Proactively manage technical authoring and regulatory compliance activities in close collaboration with a multifunctional team.
- Ensure regulatory requirements are met to facilitate continuous improvement and support projects within complex supply chains.
- Develop and maintain technical documentation for submission, including accuracy, completeness, and consistency of content.
- Own technical compliance with manufacturers' information and raw data.
- Have functional expertise and preferably appropriate external accreditation to confirm the scientific soundness of technical document content.
- Responsibilities from Day 1 - You will start working on key service strategies for all our organizations from the beginning.
- Continuous coaching and mentorship - We are passionate about our work and will make sure you receive both formal training and regular mentorship from your manager and others.
- Multifaceted and encouraging work environment - 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 and medical insurance for employees and dependents, PG stock, saving plans.
- Eligibility to work in Mexico City.
- 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 Supplement. 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 must 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.
