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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

.

Experience:

• 13 years of relevant experience

Education:

• B.Pharm or other Science degree, M.Pharm 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 time

Affiliated Companies

Affiliated Companies: PharmaLex India Private Limited

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