Specialist, Regulatory Informatics & Operations

The Specialist, Regulatory Operations has the responsibility to ensure that our clients are fully supported in all regulatory submissions with assistance from their manager or other senior team member. The candidate is expected to function with a degree of independence and is responsible for creating eSubmission compliant documents and submissions, troubleshooting, 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.
• Trouble shoot and fix issues, on a document and submission level with little assistance from the manager.
• Attend and contribute to weekly department meetings.
• Maintain professional regulatory and documentary knowledge to provide effective consulting advice.
• The Specialist may be asked to complete additional and other departmental services as required

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Requirements:

• High-level understanding of regulatory processes and CTD dossier structure - Modules 1 to 5.
• Prior experience with eDMs, RIM tools or eCTD publishing software like docuBridge, eCTD manager, Veeva or other, is not required but is an advantage.
• Ability to work according to project plan and escalate potential issues according to agreed communication plan.

Minimum skills required:

• 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.
• 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.

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 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