Regulatory Affairs Director Mexico

Pyou , an international recruitment agency, is partnering with a leading global pharmaceutical company to recruit a motivated and experienced Regulatory Affairs Manager / Director at Mexico. The company is a recognized player in the pharmaceutical sector, with a product pipeline focused on generic drugs and biosimilars. This role represents an excellent opportunity for a regulatory professional passionate about compliance and pharmaceutical regulations, eager to lead regulatory operations in a growing subsidiary. Key Responsibilities: Establish the company’s internal regulatory and compliance foundation in Mexico. Serve as the core internal regulatory and compliance lead, overseeing CRO-led registration activities. Build a regulatory management framework focused on generic drugs and biosimilars. Ensure compliance with COFEPRIS regulatory requirements. Coordinate and manage relationships with CROs or external regulatory service providers. Support the organization’s growth and prepare for increased registration volume. Contribute to strategic regulatory planning and ensure timely dossier preparation and submission. Candidate Profile: Mexican nationality . Relevant educational background in pharmacy or related fields. Fluent in English; able to use English as a working language. 6–10 years of experience in pharmaceutical regulatory affairs or related compliance roles. Strong familiarity with COFEPRIS registration processes, particularly for generic drugs and/or biosimilars. Proven experience managing CROs or external regulatory service providers. Preferred Qualifications: Experience covering both generic drugs and biosimilars. Experience in early-stage subsidiaries or new business setups. Experience managing multiple registration projects in parallel. Prior participation in NMC-related processes is a strong plus. What we offer: A leadership role in a growing pharmaceutical subsidiary. Opportunity to establish and shape regulatory operations from the ground up. A dynamic, challenging, and professional working environment. Location : Mexico City If you are interested in this opportunity, please apply directly or contact Pyou for further information. In accordance with Royal Legislative Decree 2/2015, of October 23, approving the revised text of the Workers’ Statute, Royal Legislative Decree 5/2000, of August 4, approving the revised text of the Law on Infractions and Sanctions in the Social Order, and Law 15/2022, of July 12, comprehensive for equal treatment and non-discrimination, this offer is addressed to anyone. Please read carefully the privacy policy available on our website ( ) and include in your CV the authorization to process your personal data, in accordance with EU Regulation No. 679/2016 and current Spanish legislation (Organic Law 3/2018, of December 5, on Personal Data Protection and guarantee of digital rights). Do not include data belonging to special categories (data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, genetic data, biometric data intended to uniquely identify a person, health data, or sexual orientation). We remind you that Pyou does not require, in the first phase of application submission, the sending of identification documents or other bureaucratic paperwork (e.g., personal information, data, or codes related to payment systems), and our ads always display an email address for receiving applications with one of the following company domains: @pyou.es / @lavoropiu.it We advise you to pay special attention to any communication that appears to be linked to our brand and requests scanned documents to participate in selection processes and/or interviews, especially if using email addresses with domains other than those mentioned above. In case of doubt, contact us through one of our official channels to obtain all necessary information.

Creado: Jue, 01 de Ene de 1970