Regulatory Affairs Manager at GSK in Warren, NJ
This position has responsibility for end-to-end regulatory activities for the Wellness portfolio, which is comprised of primarily dietary supplements with working knowledge of OTC drugs. Executes well-constructed and considered regulatory strategies that keep pace with the dynamic supplement and food regulatory environment. Builds strong relationships with all stakeholders, internal and external. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Growth:
Represent USRA on assigned projects, providing guidance on dietary supplement regulation and developing regulatory strategies. Includes review of formulas for local acceptability and claims development. May support products in other categories (cosmetics, OTC Drugs) as needed. Collaborate with Global and US stakeholders (commercial, Global Reg, R&D etc.) to ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, to maximize overall project delivery time and POS Occasionally provide regulatory support to ex-US markets for brands where US is the Lead Market (as defined through SRA). Stewardship:
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. External Engagement:
Monitor regulatory trends that could impact portfolio. Why you? Basic
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor's degree in Life science/Nutritional sciences/Pharmacy (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering). 5
years of experience in Regulatory Affairs 2
years working specifically within the food or dietary supplement regulations Expertise in claims development. Preferred
Qualifications:
If you have the following characteristics, it would be a plus:
RAC, RD, Master's degree or doctorate. Why GSK? Our values and expectations are 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:
Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk. Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen.
Salary Range:
$100K -- $150K
Minimum Qualification
Legal & RegulatoryEstimated Salary: $20 to $28 per hour based on qualifications.
Growth:
Represent USRA on assigned projects, providing guidance on dietary supplement regulation and developing regulatory strategies. Includes review of formulas for local acceptability and claims development. May support products in other categories (cosmetics, OTC Drugs) as needed. Collaborate with Global and US stakeholders (commercial, Global Reg, R&D etc.) to ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, to maximize overall project delivery time and POS Occasionally provide regulatory support to ex-US markets for brands where US is the Lead Market (as defined through SRA). Stewardship:
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. External Engagement:
Monitor regulatory trends that could impact portfolio. Why you? Basic
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor's degree in Life science/Nutritional sciences/Pharmacy (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering). 5
years of experience in Regulatory Affairs 2
years working specifically within the food or dietary supplement regulations Expertise in claims development. Preferred
Qualifications:
If you have the following characteristics, it would be a plus:
RAC, RD, Master's degree or doctorate. Why GSK? Our values and expectations are 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:
Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk. Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen.
Salary Range:
$100K -- $150K
Minimum Qualification
Legal & RegulatoryEstimated Salary: $20 to $28 per hour based on qualifications.
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