- Create and approve regulatory content documents that drive artwork and labeling language
- Review and approve final artwork
- Manage preparation of regulatory documents for new product launches and maintenance of current products in the market with the correct alignment and compliance to regulations
- Maintain required regulatory compliance databases, systems and processes
- Support key processes and ways of working (eg, product labeling requirements, quality, local regulations)
- Collaborate with stakeholders (commercial, R&D, etc.) to ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, to maximize overall project delivery time
- Work together with regulatory colleagues and other stakeholders (e.g. marketing, medical, legal) to proactively look for opportunities and solutions to challenges, including leading implementation of improvement initiatives
- Stay up to date with the competitive and regulatory landscape for dietary supplements, and how to apply that knowledge for new opportunities
- Navigate ambiguous regulatory scenarios and provide balanced advice in a manner that can be acted on by commercial teams.
- Leverage and interpret regulatory precedent, and other external information to supplement regulations.
- Bachelor's degree in Nutrition, Life Science, Pharmacy or related field of study
- Minimum 2+ years of experience working in Regulatory Affairs, Product Development, Medical Affairs, or related role within the dietary supplements or food industries.
- General knowledge of FDA regulations applicable to dietary supplements and/or food industry.
- Knowledge and understanding of Supplement Facts label and/or Nutrition Facts label
- Strong organizational skills with out-of-the-box thinking.
- Excellent oral and written communications skills, stakeholder management and enjoys working in multidisciplinary teams
- Registered Dietitian/Nutritionist (RDN), Certified Nutritionist (CN), Master's or other education within relevant health/science is a plus
- 2+ years working specifically in food/dietary supplements
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US Regulatory Affairs Senior Associate - Warren, United States - GSK Group of Companies
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Description
Hello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Advil, Voltaren, Theraflu, and Centrum - through a unique combination of deep human understanding and trusted science. What's more, we're achieving it in a company that we're in control of. In an environment that we're co-creating. And a culture that's uniquely ours. Care to join us. It isn't a question.The US Regulatory Affairs Sr. Associate - Wellness is responsible for end-to-end regulatory activities for the Wellness portfolio, which is comprised of primarily dietary supplements. Involves execution of well-constructed regulatory lifecycle maintenance that keep pace with the dynamic supplement and food regulatory environment. Builds strong relationships with internal stakeholders.
Role Responsibilities
Basic Qualifications:
This job posting closes on June 1, 2024
Please save a copy of the job description, as this may be helpful to refer to once the advert closes.
Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave. On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering. The salary range for this role is: $80,791 to $101,000 plus an 8% bonus.
#Li-Hybrid
Care to join us. Find out what life at Haleon is really like
At Haleon 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. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Haleon is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon's compliance to all federal and state US Transparency requirements.
