Basic Qualification -Minimum Years of experience -
6 years - 10 years.Must Have -
Regulatory CMC, Post Approval Sub, Veeva vault. Location -
Bangalore (Hybrid)Are you looking for an opportunity to support a regulatory environment where you will be a part of cost reduction initiatives and ensure submission of packages are generated and provided to markets? If so, this is the role for you.As Regulatory Affairs Management Professional you will be responsible for the execution of Chemistry, Manufacturing, and Controls (CMC) regulatory activities for new product regulations and life-cycle maintenance.This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Responsible for chemistry, manufacturing and controls of regulatory matters relating to registrations and/or maintenance of business activities
- Prepare sections of registration files, briefing books, clinical trials applications, chemistry, manufacturing and controls variations, renewals files, and responses to Regulatory Agency questions,
- Interact with colleagues in other global functions and Regulatory Affairs to deliver high quality dossiers, documents and materials to local Regulatory Affairs in accordance with business priorities
- Ensure close partnership with authors, assuring technical congruency and regulatory compliance
- Apply system and procedure updates to maintain proper records and support adequate controls
- Provide evaluations for potential changes as requested and follow up to ensure regulatory compliance and completion of appropriate internal compliance records
- Effectively communicate regulatory requirements and guidelines, facilitating timely and complete submissions
- Develop up-to-date knowledge to guidelines and regulatory requirements, as well as technical trends
Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree in Pharmaceutical or Life Sciences or equivalent regulatory experience (consult manager on equivalent regulatory experience)
- 1+ years’ experience in regulatory affairs including chemistry, manufacturing and controls, and over the counter experience
Preferred Qualifications:If you have the following characteristics, it would be a plus:
- Knowledge of regulatory submissions to markets
- Ability to ensure compliance standards and key performance indicators are met
- Regulatory expertise in knowledge of the regulatory life cycle
- Ability to interact at many levels
- Technical knowledge
Why GSK?Our values and expectationsare at the heart of everything we do and form an important part of our culture.These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- 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
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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