(Y672) GLOBAL REGULATORY SPECIALIST

Bebeeregulatory


We are a global team united by our purpose: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. Our purpose defines why we exist. About the Role Ensure that products meet regulatory requirements and are manufactured and distributed in compliance with relevant legislation. This role supports the business to establish and implement regulatory strategies within agreed timescales of product launch. - Develop and execute regulatory strategies to enable product launches according to business needs. - Provide guidance on regulations to other functions within the company. - Prepare and submit product registration, renewals and notifications ensuring product compliance with local regulations throughout the product lifecycle for all assigned products/brands/categories. - Maintain regulatory compliance with the Quality Management System (QMS) in all projects. - Verify that product labels conform to local legislation. - Review and approve artwork and advertising materials to ensure local compliance. - Meet submission registration deadlines. - Find solutions to meet product launch timelines. - Organize local product files and controls comprehensively. - Evaluate project deadlines and escalate issues if necessary. - Track regulatory submissions/approvals correctly. - Monitor official gazettes and regulators' websites to track regulation trends/changes. - Stay up-to-date on regulatory trends and local legislation, sharing this information with relevant functions and developing strategies to address them and gain a competitive advantage. - Manage regulator registration request tracking and find solutions to avoid future requests and reduce registration. - Create and request transportation sheets before the regulator in Costa Rica, following local regulations and meeting company needs. - Complete internal training in a timely manner to address corporate and regulatory needs. - Manage PSDS requests, creation and maintenance following local regulations for all products commercialized in the ANDEAN region, ensuring this information is available for all functions and activities requiring it. - Support the business with the regulatory process to maintain the portfolio up-to-date and aligned with business requirements (IDBs, MB, CC, Risk Assessment, etc.) and local regulations. Requirements - University Degree in Pharmacy, Chemistry, Biochemistry or related scientific field. - 4 years of experience in similar roles. - Fluent English language skills. - Knowledge of chemistry and hygiene registration laws. Benefits We offer a range of benefits including parental benefits, an Employee Assistance Program to promote mental health and life insurance for all employees globally. We also have short-term incentives to recognize, appreciate and reward outstanding performance. We value diversity and inclusion and welcome applications from candidates with diverse backgrounds. We believe in hiring for potential as well as experience. If you don't meet every point on the job description, but this role feels like a good fit for you, we want to hear from you.

trabajosonline.net © 2017–2021
Más información