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Regulatory Affairs Specialist

 Abbott Healthcare Pvt. Ltd

  • 1 - 5 years
  • Mumbai
  • Applicants: 0
  • Views: 53
  • Posted: 10 01 2020
  • Full Time

Job Details

Experience: 1 - 5 years

Qualification: Any graduate(Any)

Salary Offered: 2 - 4 Lakhs Annually

Functional Area: Pharmaceutical / Biotechnology

Industry: Pharmaceutical

Role: Drug Regulatory Doctor

Job Location: Mumbai

Gender: Any Gender

Number of Vacancy: 1

Job Description

Primary Job Function:

With limited supervision, coordinates and compiles regulatory documentation for submission to health authorities and contributes to Regulatory systems project to assure business needs are met and optimized for efficiency and effectiveness.

Track publishing related registration activities.

Communicate with business partners in order to track, complete, and distribute submissions.

Core Job Responsibilities:

Compile high quality submissions in compliance with technical requirements from regulatory authorities.

Project team participation to identify appropriate planning, formats, deliverables, and timelines associated with investigational and marketed product submissions across all therapeutic areas.

Coordinate submission publishing activities among internal Regulatory functions and external publishing technical resources (third party publishing resources and agency submission gateway owners).

Provide support as necessary to assure high quality published output and to meet established deadlines.

Input submission tracking information into registration tracking system.

Represent RA Operations on Regulatory sub teams as necessary, escalate timeline issues.

Implement internal process and standards relating to publishing and submission management.

Participate in and host team meetings and provide meeting minutes.

Plan and schedule own project related work.

Supervisory/Management Responsibilities:

Position Accountability/Scope:

Responsible for timely delivery of compliant regulatory submission output worldwide.

Works under limited supervision ensuring deliverable meets Abbott s internal standards.

Responsible and accountable for all steps assigned to Publishing during the submission process.

Responsible for compliant regulatory submission that impact the global Abbott business.

Accountable for tracking of complex worldwide submissions in the registration management tool.

Minimum Education:

Bachelor Degree

Minimum Experience/Training Required:

2-5 years business related experience

1-3 years minimum publishing experience

Demonstrated ability to quickly learn new technology

Expertise with EDMS (Documentum based), publishing and or registration management systems , Adobe Acrobat or demonstrated experience with similar tools

Knowledge of regulations and instructions

Expertise with electronic submission formats like eCTD, ACTD and NeeS

Demonstrated team-player

Excellent written and oral communication skills

Skills Required

adobe acrobat
edms
management systems
manager technology
supervision

Key Requirements

Primary Job Function:

With limited supervision, coordinates and compiles regulatory documentation for submission to health authorities and contributes to Regulatory systems project to assure business needs are met and optimized for efficiency and effectiveness.

Track publishing related registration activities.

Communicate with business partners in order to track, complete, and distribute submissions.

Core Job Responsibilities:

Compile high quality submissions in compliance with technical requirements from regulatory authorities.

Project team participation to identify appropriate planning, formats, deliverables, and timelines associated with investigational and marketed product submissions across all therapeutic areas.

Coordinate submission publishing activities among internal Regulatory functions and external publishing technical resources (third party publishing resources and agency submission gateway owners).

Provide support as necessary to assure high quality published output and to meet established deadlines.

Input submission tracking information into registration tracking system.

Represent RA Operations on Regulatory sub teams as necessary, escalate timeline issues.

Implement internal process and standards relating to publishing and submission management.

Participate in and host team meetings and provide meeting minutes.

Plan and schedule own project related work.

Supervisory/Management Responsibilities:

Position Accountability/Scope:

Responsible for timely delivery of compliant regulatory submission output worldwide.

Works under limited supervision ensuring deliverable meets Abbott s internal standards.

Responsible and accountable for all steps assigned to Publishing during the submission process.

Responsible for compliant regulatory submission that impact the global Abbott business.

Accountable for tracking of complex worldwide submissions in the registration management tool.

Minimum Education:

Bachelor Degree

Minimum Experience/Training Required:

2-5 years business related experience

1-3 years minimum publishing experience

Demonstrated ability to quickly learn new technology

Expertise with EDMS (Documentum based), publishing and or registration management systems , Adobe Acrobat or demonstrated experience with similar tools

Knowledge of regulations and instructions

Expertise with electronic submission formats like eCTD, ACTD and NeeS

Demonstrated team-player

Excellent written and oral communication skills

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Email: nandinigoswami@abbott.com

Contact Person: HR

Web: abbott.wd5.myworkdayjobs.com

ABOUT COMPANY

Abbott Is About The Power Of Health. For More Than 125 Years, Abbott Has Been Helping People Reach Their Potential Because Better Health Allows People And Communities To Achieve More. With A Diverse, Global Network Serving Customers In More Than 160 Countries, We Create New Solutions Across The Spectrum Of Health, Around The World, For All Stages Of Life. Whether It S Next-generation Diagnostics, Life-changing Devices, Science-based Nutrition, Or Novel Reformulations, We Are Advancing Some Of The Most Innovative And Revolutionary Technologies In Healthcare, Helping People Live Their Best Lives Through Better Health. The People Of Abbott Come To Work Each Day With Relentless Energy, Enthusiasm And A Promise To Enhance The Health And Well-being Of Millions Of People. They Push The Boundaries To Help Manage And Treat Some Of Life S Greatest Health Challenges. We Invite You To Explore Opportunities At Abbott , To See If Your Talents And Career Aspirations May Fit With Our Openings. An Equal Opportunity Employer, Abbott Welcomes And Encourages Diversity In Our Workforce.

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