Manager Regulatory Affairs

Manager Regulatory Affairs page is loadedManager Regulatory Affairs Apply locations Sao Paulo, Brazil LATAM >
Brazil >
Remotetime type Full time posted on Posted 13 Days Ago job requisition id R2510974Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today Job Details This role is in support of Cencora's global pharma consulting services marketed through our PharmaLex businessSummary:
Accountability for the execution of operational tasks in the Regulatory Strategy & Procedure Management Practice Area that requires established experience and specific scientific expertise in the sector of human and veterinary medicinal products. Responsibilities:
Develop and maintain strong client relationships and actively explore opportunities for increased service support to Local Affiliate Services. Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products. Preparation, review and compilation of documents within the framework of regulatory affairs projects. Communication with clients and Health Authorities. Support with scientific advice procedures and representation of clients with health authorities. Responsible for the planning and execution of client projects in accordance with KPIs. Coordination of project teams with colleagues and qualified external partners. General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management. Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues. Present seminars and lectures for colleagues, clients and professional audiences. Active contribution and distribution of department relevant expertise. Support with VDC strategy implementation and optimization Comply with, maintain and contribute to optimizing internal processes. Support with VDC led commercial, marketing and business development activities including proposal input. Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries. In agreement with PharmaLex contact persons, e.G. Head of VDC REG providing on-site regulatory support to GCS clients. The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with the Service Line Lead Local Affiliate Services/Practice Area Lead/Head of VDC REG.. Requirements:
Proven experience, or demonstrable capability, in area of responsibility or similar field at least 4 - 5 years in similar role. Advanced knowledge and insights required to perform complex tasks. Strong practical knowledge of service area and how it impacts the related areas. Advanced English and Portuguese. Spanish desired. Education:
University degree in Life Science or similar. Skills and Knowledge:
Ability to implement tactical goals of customer or internal projects within daily work. Ability to prioritize parallel tasks, identify potential road blocks and initiate appropriate counter measures. Structured, analytical, systematic and independent way of working;
some discretion to takeaction consistent with operating policies, determines own priorities. Ability to analyze and solve problems and to develop pragmatic solutions for a given task or project. High service orientation. Ability to train and support junior/new PharmaLex members in daily activities;
ability to lead small project with clearly defined scope. Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level. Good communication skills (written and verbally);
capability to communicate issues and propose appropriate solutions to decision makers. Good presentation skills and confident appearance. What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full timeAffiliated Companies Affiliated Companies:
PharmaLex GmbHEqual Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Similar Jobs (1) Analyst, Local Pharmacovigilance locations LATAM >
Brazil >
Remotetime type Full time posted on Posted 5 Days Ago Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them. We're a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health. Job Scams Recruitment scams are on the rise and the intent is to target individuals looking for employment opportunities. To protect yourself, we urge you to be vigilant and follow these guidelines. 1.) Research the Company:
Thoroughly research any company before applying or sharing personal information, check their website, read reviews, and verify their legitimacy. 2.) Be Wary of Unrealistic Promises:
Exercise caution If a job posting offers high salaries and minimal qualifications. Legitimate jobs will have realistic expectations and provide detailed job requirements. Jobs at Cencora can be found on Cencora.Com/careers 3.) Guard Your Personal Information:
Only share sensitive information after vetting the employer's credibility. Avoid sharing your Social Security number, bank account details, or identification documents during the application process. Cencora does not request this information as part of the employment application. 4.) Avoid Upfront Payments:
Legitimate employers do not require payment during the hiring process. Be suspicious if you are asked to pay for training materials, processing fees, or background checks before securing a job offer. Cencora will never ask you for payment information during the hiring or onboarding process. 5.) Verify Communication Channels:
Scammers often use free email services or chat platforms without providing an official company contact information. Cencora recruiters will have an email address ending in @cencora.Com, @alliance-healthcare.Net, @alliance-healthcare.Co.Uk, alliance-healthcare.Fr or alliance-healthcare.Ro Remember to stay vigilant and informed about common scam tactics to reduce the risk of falling victim to fraudulent employment schemes. #J-18808-Ljbffr

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