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Regulatory Affairs Manager

Detalles de la oferta

.Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. The Role:Solid knowledge of Regulations and Guidelines applicable to RX pharmaceutical products (biotech, small molecules) and medical devices (i.E., RIS, LGS, NOM-072, NOM-073, NOM-059, NOM-220, NOM-241, NOM-137).Responsible of setting regulatory strategies for the products assigned (NPD, LCM) to achieve regulatory approvals, always assuring full alignment with local regulations and compliance with internal SOPs and policies.SuperviseRA Coordinator activities to assure proper execution of defined strategies; provide regulatory advice and support as required. Monitor compliance with due dates.Maintain awareness of ongoing LCM projects conducted at the Hub and provide regulatory advice to define the best approach/ strategy, as needed, to assure business continuity/ MA maintenance.Identify regulatory risks and escalate with transparency and in timely manner.Review of new regulations/guidelines and provide impact analysis within RA and impacted functions.Interact closely with Local/Regional/Global RA teams and other functions such as SNO, Legal, QA, and others in order to: obtain data required for projects assigned; provide early visibility on identified risks, regulatory environment changes. Preparation of Regulatory deliverables (e.G. report generation, excel spreadsheets, power-point presentations).Assure compliance with due dates and planned dates for the products/ project assigned or under supervision.Organize and conduct training sessions within RA team to enhance regulatory knowledge. Actively participate in Technical Committees to properly update internally (Regional RA, GRASP, IBP).The delivery of regulatory guidance for projects executed at hub level is a key activity. Who you are: Bachelor´s degree in Pharmaceutical and Bioscience related science.At least 10 years of working experience in Regulatory Affairs for pharmaceutical Industry


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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