Associate Regulatory Operations

     

JOB DESCRIPTION:

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

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

EPD Established Pharma

        

LOCATION:

India > Mumbai : Mumbai Development Center - EPD

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)