Regulatory Affairs Manager

hace 2 semanas

América, México Johnson & Johnson A tiempo completo

**Job Function**:Regulatory Affairs Group**Job Sub Function**:Regulatory Affairs**Job Category**:People Leader**All Job Posting Locations**:Mexico City, MexicoOur 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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