At a glanceSummarised by Seekless from the posting.
Must have10
Creation, compilation and validation of electronic submissions (e.g. eCTD, NeeS) for all types of regulatory activities in ICH and non-ICH-areas
Electronic submission of dossiers to competent authorities via electronic submission gateways and applicable portals
Quality assurance in the field of Regulatory Operations (e.g. preparation of SOPs and WIs and corresponding training)
Testing of electronic tools for new requirements concerning regulatory operations: validation, eCTD-structure, STED, VNeeS
Training of Regulatory Operations topics, software solutions and requirements stipulated by authorities within and outside of Regulatory Affairs
SPLs
Validation errors troubleshooting
Bachelor's degree in life sciences, pharmacy, biomedical sciences, public health, or a related field, or equivalent experience
8+ years of experience in scientific consulting, healthcare, life sciences, or a related field
2+ years of experience in a management capacity
Nice to have2
Experience with Veeva Vault (RIMS and publishing preferred); extensive US publishing understanding for complete submissions like INDs/NDAs, ability to handle datasets and STFs
Certification in clinical research or regulatory affairs, health economics, outcomes research, or real-world evidence methodologies, or equivalent
Eligibility1
flexible to work US time shift
Skills
Veeva Vault
eCTD
NeeS
STED
VNeeS
SPLs
About the company
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
•
Creation, compilation and validation of electronic submissions (e.g. eCTD, NeeS) for all types of regulatory activities (e.g. MAAs, PSUR, amendments, variations, renewals) in ICH and non-ICH-areas using available software
•
Electronic submission of dossiers to competent authorities via electronic submission gateways and applicable portals
•
Quality assurance in the field of Regulatory Operations (e.g. preparation of SOPs and WIs and corresponding training)
•
Testing of electronic tools for new requirements concerning regulatory operations: requirements for validation, changes in eCTD-structure, STED, VNeeS
•
Training of Regulatory Operations topics, software solutions and requirements stipulated by authorities within and outside of Regulatory Affairs
•
Experience with Veeva Vault (RIMS and publishing preferred); extensive US publishing understanding for complete submissions like INDs/NDAs, ability to handle datasets and STFs
•
SPLs
•
Validation errors troubleshooting
•
flexible to work US time shift
.
Qualification:
•
Bachelor’s degree in life sciences, pharmacy, biomedical sciences, public health, or a related field, or equivalent experience required.
•
Experience & Skills:
8+ years of experience in scientific consulting, healthcare, life sciences, or a related field required.
2+ years of experience in a management capacity required.
Certification in clinical research or regulatory affairs, health economics, outcomes research, or real-world evidence methodologies, or equivalent preferred.
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 [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned