Vacancy for Pharma Graduates, Postgraduates at Abbott

Overview:

Abbott is hiring an experienced Associate Regulatory Operations (Publishing) at their Mumbai location. With limited supervision, this role 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.

The complete details of this job are as follows:

What will you be doing:

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.

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.

Qualifications for this Job:

Master / Bachelor science / pharmacy graduate

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

To apply for this job, visit official website

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