Associate Regulatory Operations

2 months ago

Mumbai, India Abbott Laboratories Full time

**Primary Job Function**:
**With Manager Oversight**:
Supports Drug product lifecycle management activities for EPD Global Regulatory Affairs

Specific actions and responsibilities of individual contributor include but are not restricted to:

- Awareness of end-to-end processes of the Drug product lifecycle management
- Supports the Regulatory Operations be it related to registration management, documents, and Publishing
- Progressively builds expertise and proficiency in Regulatory Operational activities
- Supports in Document lifecycle management
- Supports updating country specific Dossier structure in DARIUS for non eCTD submissions
- Supports Submission compilation activity for Global teams
- Involved in creation of Application and activities specific across product, country and dosage using basic information form (BIF) created by the Project teams
- Supports creation of published output in multiple formats (e CTD, NeeS, Export services and Paper - country specific) to be submitted at different Health authorities
- Involved in discussion with Project teams during submission planning process
- Responsible for submission dispatches through the gateways for Health Authority or CD and through affiliates
- Tracks registration activities and status to deliver on-demand reports that meet internal business needs and regulatory authority requirements.
- Contributes to Regulatory systems projects to assure business needs are met and optimized for efficiency and effectiveness.
- Delivers and drives high quality submission packages for global and local markets
- Any other Operational activities based on business needs as and when requested
- **_ Relationships & Cross Functional teamwork_**
- 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 support for Regional and Affiliate colleagues
- ** Compliance across Life-Cycle**
- Provides support for various tasks within DARIUS
- **_ Strategy_**
- Takes steps to identify, communicate, and mitigate risks
- **_ Process Improvement_**
- Identifies opportunities and suggests improvements
- **_ Technical competency_**
- Has optimal 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**:
**Minimum Experience/Training Required**:

- 2-4 years’ experience in registration management or related areas.
- Demonstrated ability to quickly learn new technology.
- Knowledge of regulations and instructions.

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