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Engaged Employer

GlaxoSmithKline Pharmaceuticals

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4.1

based on 1.8k Reviews

Video summary

63 GlaxoSmithKline Pharmaceuticals Jobs

Principal Submission Specialist

GlaxoSmithKline Pharmaceuticals Limited

4.1

based on 1.8k Reviews

5-8 years

Bangalore / Bengaluru

1 vacancy

Principal Submission Specialist

GlaxoSmithKline Pharmaceuticals

posted 5hr ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy Healthcare Operations Procurement MS Office CMS

+ 3 more

Job Description

We are currently recruiting a Principal Submission Specialist in our Submission Delivery Excellence team based in Canada, Poland or India.

Currently, Global Regulatory Operations have accountabilities for all GRA s operational activity with staff based across 8 countries (US, UK, BE, IT, IN, PO. MX, EG). Through execution of these activities, Global Regulatory Operations facilitates achievement of GRA strategic objectives including support for clinical development, new product launches and obtaining and maintaining GSK product licenses worldwide.

This position will be predominantly responsible for timely delivery of compliant regulatory submission packages to Regulatory Authorities by supporting the end-to-end processes in place for clinical applications and major submissions, providing expert guidance on technical requirements to R&D Project Teams, and planning and directing of submission support tasks in collaboration with staff in other regions.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following

Responsible for on-time delivery of electronic applications to Regulatory Authorities for submission types ranging from original NCE or Biologic applications and their associated supplements through to lifecycle submissions required to maintain applications registered status and fulfil regulatory obligations.
Integral member of the Global Regulatory Matrix Teams for high profile R&D projects. Represents overall Publishing of the project and negotiates agreements with stakeholders on specific technical aspects of major submissions and timelines for delivery which best support the needs of the R&D Project.
Accurately estimates scale and timing of publishing tasks and collaborates with Global Submission Managers, Submission Technical Support, and staff in other regions to plan and resource for delivery against aggressive timelines.
Ensures that content provided by authors are submission ready and formats to GSK standards as required.
Maintains knowledge of relevant Regulatory Authority rules and guidance associated with different formats of regulatory submissions in multiple regions (e.g. eCTD).
Building electronic submissions with standard industry software, using validated processes, and adhering to SOPs and Working Instruction documents.
Advises and guides Regulatory on submission structure and publishing/handoff approach.
Manages multiple projects/activities at different stages of development at any one time to ensure timely submission or process/system integrity

Why you?

Qualifications and Experience Required

Educational Background:

Degree in a biological, healthcare, or scientific discipline OR extensive experience within the drug development environment.

Regulatory Experience:

Minimum of 5 years of global regulatory experience.
Demonstrated experience publishing electronic submissions for a Regulatory Authority in a major region (e.g., FDA, EMA).

Technical Skills:

Proficient in the formatting of PDF documents ensuring GSK requirements and standards are met.
Knowledge of document management and publishing software and utilities.
Must have computer knowledge (e.g., MS Office, Adobe Acrobat, SharePoint, etc.) and preferably experience with the use of complex IT tools in a large organization (e.g., Veeva Vault).
Must have knowledge of detailed eCTD submission requirements in multiple regions.

Regulatory Knowledge:

In-depth knowledge of relevant regulations and standards relating to the submission of regulatory applications worldwide.

Project Management:

Strong project management skills with the ability to oversee and prioritize multiple activities across one or more sites for multiple customers.
Ability to present and actively communicate electronic submission requirements and processes and champion change, both within Global Regulatory Affairs and with key stakeholder groups in R&D.

Interpersonal Skills:

Service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment.
Strong sense of urgency, able to prioritize effectively such that key issues or emerging high-priority matters are handled in a timely and effective way.
Ability to function as a team player within a matrixed organization.

Decision-Making:

Ability to make decisions based on technical knowledge and experience within a regulated framework.
Ability to interpret published external guidance and advise on how to handle internal issues and respond to technical questions from regulators.

Employment Type: Full Time, Permanent

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