Regulatory Affairs Professional

hace 2 semanas


Xico, México Clinchoice A tiempo completo

ClinChoice is a leading global Contract Research Organization (CRO) specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

**About the Role:**

We are seeking an experienced Regulatory Affairs Professional to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with local regulations and standards for OTC and cosmetics products.

**Key Responsibilities:

- Prepare, compile, and coordinate high-quality regulatory submissions for new product launches, product updates, and throughout the product lifecycle.

- Ensure that documents to be submitted to health authorities are submission-ready by performing quality reviews before forwarding to client regulatory personnel.

- Review artwork changes and associated change controls, including tracking of deliverables.

- Monitor new and changing regulatory standards and disseminate information to relevant stakeholders.

- Support coordination of label change initiation, label reviews, and changes in accordance with regional/country review systems and procedures.

- Provide regulatory input, review, and approval related to change control.

- Develop and manage regulatory action item tables for country-specific requirements.

- Map, coordinate, and track regulatory inputs and timelines end-to-end for country requirements resulting from legal entity changes.

- Communicate internally and monitor deliverables to ensure country requirements are met by specified timeframes.

- Record and publish meeting notes, incorporating follow-up items into project deliverable tracking, ongoing monitoring, and issue escalation to client local managers.

- Manage regulatory action item tables, including mapping, coordination of regulatory inputs, and timing.

- Work with client regulatory managers to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks.

- Support client regulatory managers in their registration procedure.

- Complete market impact assessments.

- Provide weekly updates (at a minimum) to relevant client regulatory managers.

**Requirements:

- Regulatory professional with formal college or higher education in a science-related discipline.

- Relevant work experience with a minimum of 1-3 years in regulatory affairs.

- Fluency in English and local language.

- Good understanding of local regulations for OTC and cosmetics.

- Strong working knowledge of Microsoft Word, Excel, PowerPoint.

- Good communication and follow-up skills with country regulatory liaisons for clear understanding of country-specific needs for registrations, license updates, and import/export requirements.

**What We Offer:

- Competitive salary: $80,000 - $110,000 per year, depending on experience.

- Opportunities for career growth and professional development.

- Collaborative and dynamic work environment.

- Comprehensive benefits package, including health insurance, retirement plan, and paid time off.

- The chance to work on challenging projects and contribute to the success of our clients.



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