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Job Details

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

We're hiring 2 x Senior Regulatory Affairs Specialist to join our dynamic team in Bulgaria.

Primary Duties and Responsibilities    

• Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead. 

• 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.

• Support with preparation, review and compilation of documents within the framework of regulatory affairs projects.

• Communicate with clients and Health Authorities in close cooperation with the respective lead.

• Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead.

• 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.

• Support with REG strategy implementation and optimization.

• Comply with and support the maintenance of internal procedures.

• Provide operational insights to support with commercial, marketing and business development activities including proposal input in close cooperation with the respective lead.

• 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 REG providing on-site regulatory support to 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 REG.    

 

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Experience and Educational Requirements    

• Minimum of 2 years of experience in Regulatory Affairs or demonstrable capability in a relevant area or similar field.
• Experience in the pharmaceutical, biopharmaceutical, or medicinal industry is preferred.
• Advanced knowledge and insights necessary to perform processes efficiently, with a proven potential to take on more complex tasks.
• A university degree in Life Sciences or a related field.

Minimum Skills, Knowledge and Ability Requirements

• Ability to deliver on customer or internal projects / processes within daily work; ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures.

• Structured and systematic and independent way of working; limited latitude within established set of procedures, may determine priorities with little supervision.

• Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation

• Ability to train and support junior/new colleagues in daily activities; ability to lead small projects 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 solutions. Confident appearance.

• English business fluent & Bulgarian language- Essential.

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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 Bulgaria, Jsc

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