Regulatory Affairs Manager
hace 3 semanas
**Function**- Regulatory Affairs Group**Sub function**- Regulatory Affairs**Category**- Manager, Regulatory Affairs (PL7)**Location**- Mexico City / Mexico**Date posted**- Jun **Requisition number**- R- **Work pattern**- Hybrid WorkDescription**Job Function**:Regulatory Affairs Group** Job Sub Function**:Regulatory Affairs** Job Category**:People Leader** All Job Posting Locations**:Mexico City, Mexico** Job Description**:Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.**Essential Job Duties and Responsibilities**:- Develop and implement regulatory strategies for product registration, approval, and post-market compliance in Mexico.- Involvement in ODDs and Advanced therapies strategies.- Monitor changes in Mexican regulatory requirements and ensure company compliance with applicable laws, regulations, and guidelines.- Collaborate with internal departments, including R&D, Quality Assurance, Marketing, Commercial, Trade Operations and Legal to support regulatory activities and product development initiatives.- Serve as the primary point of contact for regulatory agencies in Mexico, representing the company in meetings, negotiations, and communications.- High technical knowledge in FDA and EMA marketing authorizations.- Conduct regulatory risk assessments and provide recommendations to senior management on regulatory matters impacting product development and commercialization.- Maintain accurate and up-to-date regulatory documentation, including registration dossiers, regulatory submissions, and correspondence with regulatory authorities.- Provide training and support to internal stakeholders on regulatory requirements, processes, and best practices.- Navigate in complex matrices, including regional and global.- External shaping with Regulatory Authorities.- People management & development.- CREDO & Compliance behaviors.**Minimum Qualifications**:- 8 to 10 years of experience in Regulatory Affairs- Min. 2 years of experience leading teams- MBA or M.Sc. is desirable.- Excellent verbal and written communication skills, including the ability to effectively communicate with internal and external stakeholders.- Proficiency in IT, such as MS Office, SAP, Regulatory data bases/platforms. Artificial Intelligence knowledge is preferable.- Strong analytical skills to identify gaps and root causes of issues and develop solutions.- Ability to work independently with minimum supervision to meet tight deadlines while maintaining a positive attitude- Winning mindset, calculated risk will be evaluated.- Very efficient in data integration.
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Strategic Regulatory Affairs Manager
hace 2 semanas
Mexico City Eli Lilly and Company A tiempo completoA leading global healthcare company is seeking a Regulatory Affairs Manager in Mexico City. This mid-senior level role is responsible for managing regulatory affairs activities for new product registrations and ensuring compliance with local regulations. The ideal candidate will have robust regulatory expertise, experience in team supervision, and the...
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Regulatory Affairs Manager
hace 3 semanas
Mexico City Eli Lilly and Company A tiempo completoRegulatory Affairs Manager page is loaded## Regulatory Affairs Managerlocations: Mexico, Mexico Citytime type: Full timeposted on: Posted Todayjob requisition id: R-97577At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees...
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Regulatory Affairs Manager
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Mexico City Revolut A tiempo completoAbout RevolutPeople deserve more from their money. More visibility, more control, and more freedom. Since 2015, Revolut has been on a mission to deliver just that. Our powerhouse of products — including spending, saving, investing, exchanging, travelling, and more — help our 60+ million customers get more from their money every day.As we continue our...
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Regulatory Affairs Manager
hace 3 semanas
Mexico City Revolut A tiempo completoAbout RevolutPeople deserve more from their money. More visibility, more control, and more freedom. Since 2015, Revolut has been on a mission to deliver just that. Our powerhouse of products — including spending, saving, investing, exchanging, travelling, and more — help our 60+ million customers get more from their money every day.As we continue our...
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Regulatory Affairs Manager
hace 4 semanas
Mexico City Revolut A tiempo completoAbout RevolutPeople deserve more from their money. More visibility, more control, and more freedom. Since 2015, Revolut has been on a mission to deliver just that. Our powerhouse of products — including spending, saving, investing, exchanging, travelling, and more — help our 60+ million customers get more from their money every day.As we continue our...
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Regulatory Affairs Manager
hace 4 semanas
Mexico City Revolut A tiempo completoAbout Revolut People deserve more from their money. More visibility, more control, and more freedom. Since 2015, Revolut has been on a mission to deliver just that. Our powerhouse of products — including spending, saving, investing, exchanging, travelling, and more — help our 60+ million customers get more from their money every day. As we continue our...
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Regulatory Affairs Manager
hace 3 semanas
Mexico City Revolut A tiempo completoAbout Revolut People deserve more from their money. More visibility, more control, and more freedom. Since 2015, Revolut has been on a mission to deliver just that. Our powerhouse of products — including spending, saving, investing, exchanging, travelling, and more — help our 60+ million customers get more from their money every day. As we continue our...
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Regulatory Affairs Manager
hace 3 semanas
Mexico City Revolut A tiempo completoAbout Revolut People deserve more from their money. More visibility, more control, and more freedom. Since 2015, Revolut has been on a mission to deliver just that. Our powerhouse of products — including spending, saving, investing, exchanging, travelling, and more — help our 60+ million customers get more from their money every day. As we continue our...
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LATAM Regulatory Affairs Regional Leader
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Mexico City Teleflex A tiempo completoA global medical technologies provider is seeking a Regulatory Affairs Commercial Regional Manager in Mexico, responsible for leading regional regulatory staff in LATAM markets. Candidates should have a Bachelor’s degree and over 7 years of Regulatory Affairs experience in medical devices, along with strong communication skills. The role involves...
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Strategic Regulatory Affairs Manager
hace 3 semanas
Mexico City Eli Lilly and Company A tiempo completoA global healthcare leader in Ciudad de México is seeking an individual for the Affiliates Regulatory Affairs (P3) role. The successful candidate will supervise Regulatory Affairs activities to ensure compliance and successful product registration. This role also includes fostering operational excellence and cultivating relationships with government bodies...
