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Job Details

The Senior Specialist, Regulatory Operations has the responsibility to ensure that our clients are fully supported in all regulatory submissions with some assistance from their manager. The candidate is expected to function with a degree of independence and is responsible for creating eSubmission compliant documents and submissions, quality checking, troubleshooting, and managing projects as a whole with help from the manager as required. This person will be formatting in Microsoft Word, making PDF files eSubmission compliant using specialized Adobe Acrobat plug-ins, using e-validator to quality check their work and utilizing eCTD creation software to prepare high quality submissions.

Job Description

Responsabilities:

• Build and maintain a positive and productive liaison with internal and external contacts,including interfacing with potential clients.
• Use various company and client tools for preparation/maintenance/tracking of eSubmissions
• Create and format eSubmission documents as per clients’ needs using Microsoft Word, Adobe Acrobat (and associated plug-ins), Excel, Power Point.
• Create submissions using eCTD creation software, validation and submission to Health Authorities via eSubmission portals.
• Create NeeS, and paper submissions as needed.
• Quality checking all submission types with little assistance from the manager.
• Trouble shoot and fix issues, on a document and submission level.
•  Able to respond to technical questions from Health Authorities with some assistance from their manager if required.
• Attend and contribute to weekly department meetings.
• Maintain professional regulatory and documentary knowledge to provide effective consulting advice.
• The Senior Specialist will be responsible, when requested by their manager, to train other junior department members.
• The Senior Specialist may be asked to complete additional and other departmental services as required

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Requirements:

• Good understanding and participation in regulatory processes providing high-level Regulatory Informatics & Operations support in dossier Modules 1 to 5.
• Experience with eDMs, RIM tools, eCTD publishing software like docuBridge, eCTD manager, Veeva or other.

• 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.

Minimum skills required:

• 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

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