GSK announces job opening for pharmaceutical science candidates. BSc job opening 2023, Pharmaceutical science job opening 2023, Pharmacy job opening 2023, Intrested and eligible candidates may check out all the details on the same below:
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.
Job Title: Reg Associate Manager II – Product Variations
Location: Bengaluru, India
They 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
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
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
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