Associate Regulatory Operations

Abbott

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profile Job Location:

Mumbai - India

profile Monthly Salary: Not Disclosed
Posted on: 22 hours ago
Vacancies: 1 Vacancy

Job Summary

JOB DESCRIPTION:

Job Title: Associate Regulatory Operations

RA Function: Document Operations

Job Responsibilities:

  • The Associate Regulatory Operations is responsible for processing of submission documents use of document management tools perform quality checks on own and other team members to ensure compliance with Abbott/Regulatory Authority formatting standards.
  • The individual needs to work effectively with Operations team members Regulatory colleagues and Publisher to assure high quality documents and to meet established deadlines of submission packages.
  • The Individual must have excellent written & oral communication skills in English & be able to work with business partners globally.
  • The individual will also perform other regulatory operations activities as needed.
  • The individual supports departmental projects and less experienced colleagues.
  • The individual contributes in settings standards and developing training materials on document operations activities.
  • The individual contributes in process improvement system enhancement and provide assistance in troubleshooting issues with software and processes.

Minimum Education and/or Equivalent Experience and/or Other Experience/Training Required for this Job Role:

  • Life Sciences Graduation or above
  • 3-5 years Regulatory experience or 3-5 years in R&D or related area
  • Familiarity with pharmaceutical regulatory or labelling documents.
  • Verbal and written communication skills.
  • Experience with MS Word formatting.
  • Document management experience.
  • Ability to quickly learn and use document management based computer systems.
  • Must be process oriented with a strong attention to detail.
  • Ability to work in a fast paced team environment and re-prioritize work to meet business needs.

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)


Required Experience:

IC

JOB DESCRIPTION:Job Title: Associate Regulatory OperationsRA Function: Document OperationsJob Responsibilities:The Associate Regulatory Operations is responsible for processing of submission documents use of document management tools perform quality checks on own and other team members to ensure c...
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Key Skills

  • Business
  • Information Management
  • Accounting
  • Corporate Risk Management
  • Faculty
  • Jms

About Company

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WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more

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