Jobs

Interviews
Job Alerts
Tools

Upskill and Grow with AI

Mock Interview Practice interviews in realistic simulations

Coding Practice Improve your coding skills with challenges

Certification Earn certifications to validate your skills

AI Learning Get trained with AI expert sessions

Career Path AI insights for smarter career decisions

AI Job Match Score AI-Powered Job Match Against Your Resume and Optimize Your Resume

Career Tools and Resources

Resume Builder Build Professional Resume with Ease

ATS Friendliness Check Check Resume Friendliness for Applicant Tracking Systems

Auto Apply Apply to hundreds of jobs on any platform effortlessly

Co-Pilot (Chrome Extension) Your AI Assistant for Seamless Browsing Efficiency

Interview Questions Streamline interviews with ready-to-use questions

Salaries Discover market-driven salary insights across skillsets and geographies

Companies Explore leading companies actively hiring talent
For Employers

Jobs

Interviews

Home
>
Jobs in noida
>
World Courier
>
Senior Specialist, Regulatory Affairs

Senior Specialist, Regulatory Affairs

World Courier

3 - 6 years

5 - 8 Lacs

noida

Posted:None| Platform:

Apply

Skills Required

training adobe acrobat operational support publishing pdf quality check consulting troubleshooting microsoft operations

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Details

The Senior Specialist, Regulatory Operations has the responsibility to ensure that our clients are fully supported in all regulatory submissions with some assistance from their manager. The candidate is expected to function with a degree of independence and is responsible for creating eSubmission compliant documents and submissions, quality checking, troubleshooting, and managing projects as a whole 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

PRIMARY DUTIES AND RESPONSIBILITIES:

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.
Quality checking all submission types with little assistance from the manager.
Trouble shoot and fix issues, on a document and submission level.
Able to respond to technical questions from Health Authorities with some assistance from their manager if required.
Attend and contribute to weekly department meetings.
Maintain professional regulatory and documentary knowledge to provide effective consulting advice.
The Senior Specialist will be responsible, when requested by their manager, to train other junior department members.
The Senior Specialist may be asked to complete additional and other departmental services as required

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

Good understanding and participation in regulatory processes providing high-level Regulatory Informatics & Operations support in dossier Modules 1 to 5.
Experience with eDMs, RIM tools, eCTD publishing software like docuBridge, eCTD manager, Veeva or other.
Ability to deliver on customer or internal projects / processes within daily work; ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures.
Structured and systematic and independent way of working; limited latitude within established set of procedures, may determine priorities with little supervision.
Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation
Ability to train and support junior/new colleagues in daily activities; ability to lead small projects with clearly defined scope.
Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level.
Good communication skills (written and verbally); capability to communicate issues and propose solutions. 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.

Full time

Affiliated Companies Affiliated Companies: PharmaLex India Private Limited

More Jobs at World Courier

ServiceNow Developer

Pune

5.0 - 10.0 yrs

INR 5 - 9 Lacs

REG - CMC - Senior Specialist

Noida

3.0 - 6.0 yrs

INR 9 - 13 Lacs

Senior Specialist / Assistant Manager

Noida

5.0 - 7.0 yrs

INR 6 - 10 Lacs

Salesforce Developer

Pune

3.0 - 8.0 yrs

INR 4 - 8 Lacs

Analyst III - Finance

Pune

2.0 - 7.0 yrs

INR 4 - 9 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

Enhance Your Skills

Practice coding challenges to boost your skills

Start Practicing Now

World Courier

Login to

Please Verify Your Phone or Email

Confirm Action

Search

Profile

Upskill and Grow with AI

Senior Specialist, Regulatory Affairs