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:
- Represent USRA on assigned projects, providing guidance on dietary supplement regulation and executing regulatory strategies. Includes review of formulas for local acceptability and claims development. May also have some Cosmetic products in portfolio.
- Collaborate with US stakeholders (commercial, R&D etc) to ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, to maximize overall project delivery time and POS
- Provide regulatory support to ex-US markets for brands where US is the Lead Market (as defined through SRA)
- Support end-to-end regulatory compliance of products in remit.
- Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.
- Proactively identify potential regulatory risks and recommend solutions within defined scope of responsibility on the business.
- Review labeling and formulations for acceptability.
- Maintain high level of knowledge on the science of products within defined portfolio.
- Monitor regulatory trends that could impact portfolio
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in Pharmaceutical or Life Sciences
- 2+ years' experience in regulatory affairs including chemistry, manufacturing and controls, and over the counter experience
- Dietary Supplement 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
*LI-GSK Why Consumer Healthcare?
Right now, we're on an incredible journey as we prepare to become the first independent, 100% focused consumer healthcare company. We're doing this at a time when the work we do has never mattered more. Better everyday health is about improving the health and wellness of the consumers that we touch every year - over a billion and a half of them - and it goes beyond products. It's about truly helping people manage their health proactively in different ways as consumer needs evolve. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we're uniquely placed to do this and to grow a strong, successful business. This is an exciting time to join us and help shape the future. It's an opportunity to be part of something special. Diversity, Equity and Inclusion
In Consumer Healthcare we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.
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