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)
