Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

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:

Regulatory Affairs:

• 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 Key Performance Indicators. 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 Value Delivery Centre strategy implementation and optimization.

• Comply with, maintain and contribute to optimizing internal processes.

• Support with Value Delivery Centre 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 Value Delivery Centre Regulatory providing on-site regulatory support to Global Consulting Services 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 Value Delivery Centre Regulatory.

Pharmacovigilance:

• Set up and manage the local pharmacovigilance system, including oversight of local Pharmacovigilance activities.

• Local Literature Search.

• Local Individual Case Safety Report Collection and Management.

• Pharmacovigilance Intelligence Screening.

• Local Pharmacovigilance System Master File Maintenance.

• Setting up Local Organized Data Collection.

• Local Pharmacovigilance Agreement Management.

• Local adaptation and submission of Periodic Safety Update Reports/Risk Management Plan.

• Local signal detection.

• Implementation of additional Risk Minimization Measures.

• Reviewing materials relating to local post-authorization safety studies.

• Participate in Pharmacovigilance-relevant audits and inspections.

• Attend regular meetings according to project meeting schedule.

• Provide monthly Pharmacovigilance report on status of local Pharmacovigilance system in the country/ies.

• Ensure Pharmacovigilance training of affiliate employees, service providers and Third Parties.

• Close cooperation with the global Pharmacovigilance system of the client as well as related global and local departments and functions.

Quality Management Control:

• Quality Management system maintenance/Quality Management Review.

• Change control, deviation, and Corrective and Preventive Actions.

• Management of Quality Technical Agreements.

• Internal and external audits.

• Self-Inspections.

• Training.

• 3rd Party Logistics/Local Distributor Oversight.

• Oversight of local labelling activities.

• Local release of batches.

• Qualification of suppliers and customers (Bona-fide).

• Management of returns.

• Management of quality product complaints and incidents.

• Local Regulatory intelligence.

• Preparation of Product Quality Review/Annual Product Review.

• Contact point to local regulatory authorities.

• Local Responsible Person and/or Qualified Person where required.

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Education:

• University degree in Life Science.

Experience:

• 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.

Minimum Skills, Knowledge and Ability Requirements:

• 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.

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.

Affiliated Companies

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