Submission Planner @ Golden Opportunities

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Submission Planner

Golden Opportunities
2 - 8 Years
Chennai
4 years ago
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Job Description

Candidate Specification:

Preferred Educational Qualification for the role: Bachelors degree in science or related field
Preferred experience for the role: Experience in Regional planning activity and or extensive submission publishing experience.
At least 2 years experience in regulatory operations area regulatory affairs will be asset.

Submission Planner Responsibilities:

The Regional Submission Planner will work within the MSD Global Regulatory Affairs and Clinical Safety (GRACS) organization in the Regulatory Affairs Operations International Regional department (Asia Pacific [AP]). The SUPPLIER resources will be co-located in the regions.
The Regional Submission Planner supports the regulatory submission creation and the registration tracking of the company regulatory submission targets from a regulatory operational perspective for the whole region.
The key deliverable for the Regional Submission Planner is the submission component plan created in the planning tools and following standard processes.
This plan will be attached to a submission publishing request for the submission to be published and submitted in each identified country.
As a member of cross-functional team and for the assigned products he/she manages all operational aspects from submission planning document collation to submission creation and delivery to Health Authorities.
This position requires a high-level expertise and knowledge of the regulatory landscape across each respective region its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g. eCTD and other submission formats

Employement Category:

Employement Type: Full time
Industry: Pharmaceutical
Functional Area: Operations
Role Category: Regional Manager
Role/Responsibilies: Submission Planner

Contact Details:

Company: Golden Opportunities
Location(s): Chennai

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Designation / Expected Role

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Experience (*)

Expected Salary (*)

Desired Industry (*):

Functional area / Department (*):

Enter Skills (key skills, subjects, technologies & roles to use in search)

Write briefly about yourself, your experience and education (*)

Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

Please, check the file size and type.

Add social media [ + ]

Create password

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Submission Planner @ Golden Opportunities

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