Job Information
Abbott Associate Regulatory Operations in Mumbai, India
Primary Job Function:
With Manager Support:-
Supports EPD Regulatory Affairs (EPD-RA) by taking responsibility for the following activities:
Maintaining and managing documents in Document management system. Responsible for managing the workflow and version controlling of the documents in the system
Support document formatting using MS word functionalities, styles, recommended formats as needed
Support making PDF document submission ready by use of PDF feature and ISI Toolbox plug-ins
Performing quality checks of documents (format perspective)
Supports submission compilation of documents into submission binders
Fixes Best practices to make the documents submission ready
Interacts and coordinates with key stakeholders like Regional Product leads, affiliates, CMC and other Global Regulatory Strategic teams
Manages the country specific dossier structure across varied regions (especially non eCTD countries)
Maintains request level data through effective trackers which is used for Monthly reporting of the data
Exhibit team spirit and manage timely delivery of importing of documents into Document Management system or any other ad hoc requests in time
Training new DARIUS users and/or new team members as and when requested
Support any other operational activities based on business needs as and when requested
Specific actions and responsibilities of individual contributor includes but are not restricted to:
1. Relationships & Cross Functional team work
-Supports prioritised projects and activities across EPD RA
-Monitors and communicates actual versus planned activities and timelines
-Identifies and communicates risks and issues impacting day-to-day activities
-May represent Regulatory Operations at relevant project meetings and communicates agreed GRA position
2. Affiliate Coordination
-With manager agreement, provides submission compilation support for Regional and Affiliate colleagues
3 . Compliance across Life-Cycle
-Provides support for submission compilation and building of registered positions in DARIUS
4. Strategy
-Takes steps to identify, communicate, and mitigate risks
5. Process Improvement
-Identifies opportunities and suggests improvements
6. Technical competency
-Has extensive knowledge of processes and systems such as DARIUS used within EPD-RA
CORE COMPETENCIES
Adaptability
-Works with manager to define short-term (days) work tasks
-Works with manager to regularly review the status of work tasks
-Reacts quickly to solve problems and issues when they arise
Initiative
-Attempts to anticipate, mitigate and avoid problems and issues
-Seeks feedback from manager and team members and adapts behaviour to improve performance
Innovation
-Is aware of the need to develop an intrapreneurial mindset to identify new or unique ways to address work problems or opportunities
Integrity
-Delivers high quality results.
-Meets agreed deadlines.
-Exhibits honesty and presents complete impartial information.
-Displays consistency between words and actions.
-Acknowledges and responds constructively to failures and mistakes.
-Expresses dissatisfaction constructively, without over-reacting.
Teamwork
-Interacts with colleagues to complete team and shared goals
LEADERSHIP COMPETENCIES
Set Vision and Strategy
-Provides information to Document Operations colleagues and business partners to build strategies
Build Organization and Inspire People
-Shares knowledge and previous experience with peers
Drive Results
-Completes goals according to agreed deadlines
Make Difficult Decisions
-Provides information to help with decision-making within scope of project/product responsibilities
Encourage an Open Environment and Knowledge Sharing
-Provides honest, accurate feedback to colleagues, whether positive or negative
-Not afraid to challenge peers and be challenged
-Openly shares information with peers
Supervisory/Management Responsibilities:
Direct Reports None (individual contributor)
Indirect Reports : None (individual contributor)
Minimum Education:
Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject
Minimum Experience/Training Required:
A minimum of 5 years of experience in Regulatory Affairs, R&D, Manufacturing or related areas
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com