Manager Regulatory Informatics and Operations

PharmaLex India Private Limited; Dadri; Hybrid; INR 3,000,000 - 7,000,000; Full time

Benefits offered by this job

Benefits vary by country

Equal employment opportunity

Job summary

Cencora is seeking a senior Regulatory Operations professional to lead electronic submissions (eCTD/NeeS) for MAAs, PSURs, and variations. You will ensure quality and compliance while handling data sets and Asia/US publishing standards.

The role requires 8+ years in life sciences, with 2+ years in management and strong experience in Veeva Vault and regulatory software. Eligibility for global postings varies by country; US publishing knowledge is essential.

Qualifications

• Bachelor's degree in life sciences or related field or equivalent.
• 8+ years in scientific consulting, healthcare or life sciences.
• 2+ years in a management capacity; regulatory/clinical research certification preferred.

Responsibilities

• Create, compile and validate electronic submissions (eCTD, NeeS).
• Submit dossiers to authorities via portals and gateways.
• QA in Regulatory Operations; draft SOPs and training materials.
• Train staff on regulatory software and authority requirements.

Skills

Regulatory affairs

eCTD/NeeS expertise

Veeva Vault experience

US publishing knowledge

Team management

Education

Bachelor's degree in life sciences, pharmacy, biomedical sciences, public health

Tools

Veeva Vault

eCTD portals

Job description

About the Role

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.

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 .

Qualifications

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

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.

We will make accommodation determinations on a request-by-request basis.

Messages and emails regarding anything other than accommodations requests will not be returned.

About Cencora

Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them. We’re a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health.