Regulatory Affairs Operations Analyst

hace 2 meses

Bogotá Cundinamarca, Colombia Haleon A tiempo completo

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Dolex, Coega, Today and Centrum - through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating and a culture that’s uniquely ours. Care to join us.

The Regulatory Operations Analyst - LATAM provides operational support for compliance activities within LATAM, including documentation management, training, audit support, and CAPA follow-up when needed. This role ensures regulatory risks are identified and mitigated, supports LATAM systems like VEEVA, and collaborates on regional regulatory submission activities. The analyst works closely with local regulatory teams to address regulatory matters and contributes to the development and execution of global and regional compliance, innovation & maintenance strategies.

Key Responsibilities
- Support portfolio CMC documentation creation for regulatory submissions and the applicable compliance management within the LATAM Regulatory Affairs (EMEA/LATAM, if required) organization, ensuring adherence to global, regional, and local processes, policies, SOPs, and working instructions.
- Support best practices for Regulatory Affairs processes and optimization during the implementation of new systems or regulatory activities Connected with the change control process.
- Provide solutions to complex problems requiring data analysis and evaluation of intangible variables, including support for portfolio CMC maintenance, VEEVA, etc.
- Collaborate on process improvements and issue resolution for compliance issues, helping to review and enhance existing processes.

Why you?

Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:

- Bachelor’s degree in Pharmacy, Chemical Engineering or related fields.
- 2 years of experience in Regulatory Affairs, CMC or Quality documentation in FMCG or pharma industries.
- Advanced level of English.

Diversity, Equity and Inclusion

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.

We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.

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