Regulatory Publishing Associate

Site Name: India - Andra Pradesh - Hyderabad

Posted Date: Nov 2+ 2021

Are you looking for a regulatory Publishing Associate role that will enhance your documentation knowledge and allow you to help shape systems strategy? If so, this could be an exciting opportunity to explore.

These Responsibilities Include Some Of The Following

This role will provide YOU the opportunity to lead key activities to progress YOUR career.
• Responsible for the publishing of centrally supported regulatory dossiers for regulatory affairs category teams, either for direct submission to regulatory authorities, or for submission via local regulatory teams.
• Responsible for the publishing of R&D clinical study reports for the medical operations team.
• Participate in publishing activities and resource management of all assigned submissions/reports/documents in compliance with internal and external publishing quality standards. Works in a collaborative effort with regulatory associates from central function and LOC to ensure assigned submission work is accomplished to agreed timings.
• Prioritize publishing work on dossiers and study reports in order to meet agreed regulatory targets. Work may be self-prioritized or may come from a more senior-level person in the group as part of a larger work plan.
• Develops good working relationships with internal and external customers to facilitate effective communication and to ensure that customers adhere to publishing quality expectations and timelines with respect to the submission assembly and publication process.
• Supports regulatory & medical customers to resolve publishing related issues, with support from senior management as required.
• Provides advice and guidance on the production and publishing of regulatory submissions to R&D project teams, and regulatory affairs directly, to agree approaches and timelines for the supply of submission documents and data for submission preparation.
• Contributes (as per assigned goals) to the evolution of publishing capability, including system enhancements, best-practice process improvements and regulatory intelligence.

Why you?

Preferred Qualifications

If you have the following characteristics, it would be a plus:
• Bachelor’s degree
• 1-4 year of publishing experience of medicinal dossiers in electronic format; preferable in eCTD format
• Excellent verbal and written communications skills
• Ability to work carefully under time constraints and prioritize accordingly
• Adaptable to fast-paced environments with changing circumstances, direction, and strategy
• Exposure to work within a regulated environment, ideally in drug development

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

As GSK Focuses On Our Values And Expectations And a Culture Of Innovation, Performance, And Trust, The Successful Candidate Will Demonstrate The Following Capabilities

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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