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Manager, Regulatory Affairs

Manager, Regulatory Affairs

CencoraDes Moines, IA, US
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Regulatory Strategy & Procedure Management Professional.Our team members are at the heart of everything we do.At Cencora, we are united in our responsibility to create healthier futures, and every ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Public Policy Manager

Public Policy Manager

Paribus (Ramp)Des Moines, IA, US
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Our mission is to empower businesses by delivering financial infrastructure that is secure, fair, and frictionless.As we grow, the policy and regulatory environment around fintech is rapidly evolvi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Microsoft Public Sector Client Account Executive

Microsoft Public Sector Client Account Executive

HSODes Moines, IA, US
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Public Sector Client Account Executive.As a Public Sector Client Account Executive you can expect to.Build and maintain strong relationships with existing HSO clients while actively seeking opportu...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Director External Affairs

Director External Affairs

Des Moines UniversityWest Des Moines
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At Des Moines University Medicine and Health Sciences (DMU), we are committed to transforming health and reimagining the future of medical and health sciences education. In this pivotal role, you’ll...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Associate Director, Regulatory Scientific & Quality Affairs

Associate Director, Regulatory Scientific & Quality Affairs

Larson MaddoxDes Moines, IA, United States
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A global leader in ingredient innovation is seeking a senior regulatory and quality professional to oversee compliance and strategy for its health-focused product portfolio.This organization operat...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Director Public Policy

Director Public Policy

Alzheimer's AssociationWest Des Moines, Iowa, US
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The Director of Public Policy serves as the principal staff for state government affairs and chief lobbyist in Iowa, representing the Alzheimer’s Association before Iowa’s legislature, governor, re...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Senior Community & Public Affairs Specialist

Senior Community & Public Affairs Specialist

Alliant EnergyDes Moines, IA, US
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Senior Community & Public Affairs Specialist.Bring your energy to Alliant Energy! At Alliant Energy, our purpose is to serve customers and build stronger communities. We are passionate about powerin...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
Tax Staff - Public

Tax Staff - Public

Robert HalfClive, IA, United States
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Description We are looking for an experienced Tax Staff member to join our team in West Des Moines, Iowa.This position offers an excellent balance between public accounting tax work and manageabl...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Public Adjuster

Public Adjuster

The Misch GroupDes Moines, Iowa, US
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Production Public Adjuster (Licensed).Primary Locations : KS City, Des Moines IA, State of CO, State of CA, St.Louis, State of IL with emphasis on Chicago. Must have Public Adjuster License.Must have...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Campus Public Safety Officer

Campus Public Safety Officer

SecuritasDes Moines, Iowa, USA
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Campus Public Safety Officer Full Time Des Moines IA.Former Military / Law Enforcement Encouraged To Apply!!.Thinking about a job in the security field. Securitas employees come from all walks of ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Product Development & Regulatory Affairs - Annuities

Product Development & Regulatory Affairs - Annuities

Global Atlantic Financial GroupDes Moines, IA, US
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Product Development & Regulatory Affairs - Annuities.Global Atlantic is a leading provider of retirement security and investment solutions with operations in the U. As a wholly-owned subsidiary of K...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Community & Public Relations Specialist

Community & Public Relations Specialist

Homemakers Plaza, IncUrbandale, IA, United States
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Homemakers is looking to add a talented community minded representative to our marketing team.If you possess the desire to help others, make a difference, and create positive relationships then we ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Assistant Federal Public Defender

Assistant Federal Public Defender

Iowa Southern Federal Public DefenderDes Moines, IA, US
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Job Details for Assistant Federal Public Defender.Court Name / Organization : Iowa Southern Federal Public Defender.serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Psychologist - Contractor - Veteran Affairs Disability Evaluations

Psychologist - Contractor - Veteran Affairs Disability Evaluations

Valor Healthcare, Inc.Carlisle, IA, US
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Mission Critical Valor (MCV), a subsidiary of Valor Healthcare, is the leading provider of comprehensive psychological services to the Departments of State, Defense, Justice, and Homeland Security....serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Senior Regulatory Affairs Engineer

Senior Regulatory Affairs Engineer

Neko HealthDes Moines, IA, US
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Senior Regulatory Affairs Engineer.Join Neko Health as Senior Regulatory Affairs Engineer.Are you ready to shape the future of medical technology? Neko Health is seeking a Senior Regulatory Affairs...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Tax Staff - Public

Tax Staff - Public

Iowa StaffingClive, IA, US
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We are looking for an experienced Tax Staff member to join our team in West Des Moines, Iowa.This position offers an excellent balance between public accounting tax work and manageable hours during...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Senior Principal Regulatory Affairs Specialist

Senior Principal Regulatory Affairs Specialist

Bausch + LombDes Moines, IA, US
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Senior Principal Regulatory Affairs Specialist.Bausch + Lomb (NYSE / TSX : BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people a...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Intern I - Regulatory Affairs

Intern I - Regulatory Affairs

DexComDes Moines, IA, US
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Dexcom's Summer Intern Program.Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream : To forever ch...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Global Affairs Specialist - 100022

Global Affairs Specialist - 100022

Drake UniversityDes Moines, US
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Drake University is seeking a dynamic and accomplished international education administrator to serve as the Global Affairs Specialist - Asia Programs at Drake University.This role will provide adm...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Manager, Regulatory Affairs

Manager, Regulatory Affairs

CencoraDes Moines, IA, US
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Regulatory Strategy & Procedure Management Professional

Our 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.

Purpose & Contribution Summary :

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.

Primary Duties and Responsibilities :

  • Develop and maintain strong client relationships and actively explore opportunities for increased service support to Line Manager.
  • 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 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 their Line Manager / Practice Area Lead / Head of VDC REG.

Experience and Educational Requirements :

  • Proven experience, or demonstrable capability, in area of responsibility or similar field, advanced knowledge and insights required to perform complex tasks and strong practical knowledge of service area and how it impacts the related areas.
  • University degree in Life Science.
  • Minimum Skills, Knowledge and Ability Requirements :

  • Local RA experience on the Georgian market in terms of new MAA and lifecycle management. (mandatory, around 5 years), PV and / or QA / QC experience (beneficial)
  • 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 take action 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 colleagues 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.
  • English business fluent & local language (as appropriate). Fluent in Russian (benefit).
  • 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.

    Equal 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 hrsc@cencora.com.