Regulatory Affairs Coordinator
hace 2 meses
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, Corega, Centrum, Alikal, Uvasal, Hinds - 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 Affair Coordinator is responsible for provide support and manage all regulatory activities (for categories such as OTC, Cosmetics, Dietary Supplements, Medical Devices, etc.) with the purpose to get the corresponding BoH approvals for new products, and maintain the registered products updated, according to local/regional plans and strategies based on local legislation and corporate policies for Argentina and any impacted market under this area of responsibility.
Key Responsibilities:
This role gives YOU the opportunity to lead key activities to progress YOUR career, the main of these are:
- Prepare dossiers for BoH regulatory submissions of new products, variations, renewals, etc, in order to maintain the product licences updated. Follow up of the submitted files.- Address queries received from the BoH involving Regulatory Affairs CentralTeam, if required, follow up and prepare response.- Strategy definition and management of innovation projects.- Request CFS, CoPP, GMP, etc for foreign countries.- Review and approve promotional materials & artworks.- Provide regulatory feedback to Regulatory Affairs Central Team, regional and local team, when requested.- Prepare local and harmonized labels.- Update the appropriate corporate and BoH databases as required.- Prepare and update SOPs.- Maintain the applicable products conformance files updated.
Why you?
Basic Qualifications:
We are looking for professionals with these characteristics to achieve our goals:
- University degree in Pharmacy, Chemistry, Biochemistry or related areas.- At least 4 years of experience in Regulatory Affairs for Consumer Health industry in categories as OTC, Cosmetics, Dietary Supplements, Medical Devices, etc.- Advanced level of English.- Knowledge of the Argentinean regulatory legislation.
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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