Manager Regulatory Informatics and Operations
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Job Location:
Monthly Salary:
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
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
Responsibilities:
Create compile and validate e-CTD and Nees including Original Submissions i.e. NDA IND ANDA DMF BLA MAAs IMPD for USFDA Canada TGA GCC EU etc.
Expertise in eCTD Submission managements planning publishing strategy and repository.
Involved in Pre-Approval & Post-Approval Submissions i.e. Amendment Variations (FRC DRL IR and CR Type II Variation) and Post-Approval (CBE-0 CBE-30 PAS and AR Renewals labelling supplements) PADER DSUR PSUR OPDP REMS DMF submission and Review & uploading of Clinical & Non-Clinical Study Reports (Module 4 and 5) and Creating of STF Leaf Title as per ICH Guidelines for USFDA.
100 BA/BE studies tagged in STF Format with CSRs CRFs & Datasets in eCTD/ICH E3 Format.
Experience in Compilation Publishing Submission & Life Cycle management of e-CTD submission (NDA ANDA DMF) for US (US-FDA) and EU Canada Australia GCC ROW.
Aware about the current expectation of different regulatory authorities like USFDA EU GCC Canada Australia for e-CTD requirements.
Ensure Regulatory submissions with FDA ESG EMA CESP & MHRA gateways to submit final published eCTD sequences.
Perform quality review of Regulatory Operations team members work to ensure accuracy and to maintain quality delivery of all assigned projects.
Involved in end-to-end Regulatory Operations activates such as per-doc publishing submission validation dispatch & archival
Team Management
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Experience:
13 years of relevant experience
Education:
or other Science degree preferred.
Skills:
Submission publishing (mandatory) US Publishing experience
Veeva tool experience (preferred) Veeva Publishing experience
Flexibility:
Must be open to working in shifts if required
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 timeAffiliated Companies
Affiliated Companies: PharmaLex India Private LimitedEqual 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 companys 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 . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
