Abbott
Website:
abbott.com
Job details:
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 :
- 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
- 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
- Strategy
- Takes steps to identify, communicate, and mitigate risks
- Process Improvement
- Identifies opportunities and suggests improvements
- 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
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