Manager Regulatory Affairs

AmerisourceBergen; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical consulting company seeks a Regulatory Strategy Consultant that will focus on operational tasks within regulatory affairs for both human and veterinary products. The role requires strong interpersonal skills, regulatory knowledge, and the ability to work collaboratively with clients and health authorities, contributing to innovative solutions in the health sector.

Benefits

Competitive salary

Health benefits

Professional development opportunities

Qualifications

• At least 4 - 5 years in a similar regulatory role.
• Advanced knowledge of regulatory affairs.
• Advanced English and Portuguese; Spanish is a plus.

Responsibilities

• Develop and maintain strong client relationships.
• Participate in regulatory processes for product authorizations.
• Prepare and review regulatory project documents.

Skills

Client Relationship Management

Regulatory Knowledge

Project Planning

Communication Skills

Analytical Skills

Problem Solving

Education

University degree in Life Science

Job description

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. Apply today!

This role is in support of Cencora's global pharma consulting services marketed through our PharmaLex business

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.

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 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 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 time

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. Apply today!

Job Details

This role is in support of Cencora's global pharma consulting services marketed through our PharmaLex business

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.

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 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 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 time

Affiliated Companies

Affiliated Companies: PharmaLex GmbH

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 [e-mail] . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

About the company

AmerisourceBergen Corporation is an American drug wholesale company that was formed by the merger of Bergen Brunswig and AmeriSource in 2001.

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