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Regulatory Affairs Specialist

Regulatory Affairs Specialist

AmerisourceBergen Corporation (Cencora)Atlanta, GA, United States
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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

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.

We are looking for a Regulatory Affairs Specialist in Georgia to join our growing team. This role is open to graduates with a Life Sciences degree and / or anyone with experience in the relevant areas.

Responsibilities :

  • Assist the project leads in the Regulatory Strategy & Procedure Management Practice Area in operational tasks and all aspects of technical delivery and project management.
  • 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 respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries.

Experience :

  • Basic experience in area of responsibility or demonstrable capability from a similar field; ability to acquire knowledge "on-the-job".
  • Education

  • University degree in Life Science
  • Skills :

  • Local experience on the Georgian market in terms of lifecycle management. (beneficial), Pharmacovigilance and / or Quality Assurance or Quality Control experience (beneficial)
  • Ability to work according to project plan and escalate potential issues according to agreed communication plan.
  • Structured way of working; limited latitude within established set of procedures, may determine priorities with general supervision.
  • Resolves routine (and some non-routine) problems in a thorough and timely manner.
  • Attention to detail. High service orientation.
  • Ability to prioritize and manage own time and tasks.
  • Ability to convey a positive message about Pharmalex
  • Good communication skills (written and verbally); capability to point out issues and provide potential options for solution in the area of expertise. 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.

    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 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

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    Regulatory Specialist • Atlanta, GA, United States

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