FDA Product Regulatory Manager
FDA Product Regulatory Manager
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Job Description
At Dow we believe in putting people first and were passionate about delivering integrity respect and safety to our customers our employees and the planet.
Our people are at the heart of our solutions. They reflect the communities we live in and the world where we do business. Their diversity is our strength. Were a community of relentless problem solvers that offers the daily opportunity to contribute with your perspective transform industries and shape the future. Our purpose is simple - to deliver a sustainable future for the world through science and collaboration.If youre looking for a challenge and meaningful role youre in the right place.
Dow (NYSE: DOW) is one of the worlds leading materials science companies serving customers in high-growth markets such as packaging infrastructure mobility and consumer global breadth asset integration and scale focused innovation leading business positions and commitment to sustainability enable us to achieve profitable growth and help deliver a sustainable future. We operate manufacturing sites in 30countries and employ approximately36000 people. Dow delivered sales of approximately$43 billionin 2024. References to Dow or the Company mean Dow Inc. and its subsidiaries. Learn more about us and our ambition to be the most innovative customer-centric inclusive and sustainable materials science company in the world by visiting.
Dow has an exciting and rewarding opportunity for a Product Regulatory Manager working with the FDA! This role will be based in Midland MI. Will any consider any Dow site in the United states or U.S. Virtual Office.
The North America Product Regulatory Services (PRS) team as a part of the Global Product Safety organization provides regulatory leadership to clients (Dow businesses) JV partners and external customers by promoting and protecting their licenses to sell franchise products by managing compliance opportunities and risks. NA PRS provides expertise and services for different regulatory frameworks across North America.
Dows North America Product Regulatory Services (NA PRS) has an exciting and challenging opportunity available for a Regulatory Manager with focus on US Food and Drug Administration (FDA) regulations. The primary location listed is Midland MI; however this role can be located at other Dow locations in the United States. Flexible work arrangements (including virtual office) are available.
Responsibilities/Duties:
General FDA Services
- Provide value-added interpretation and consulting services to the businessesand assist clients in completing regulatory submittals and reporting requirements.
- Provide regulatory change management and trends analysis to advise the businesses in the interpretation of new and existing regulations. Assists businesses/functions with determining required level of GMP for products based on intended end use application.
- Conduct compliance assessments and safety assessments for new or changed products production aids and/or additives.
- Liaison with external consultants for third party opinions/consultations.
- Prepare submissions to US FDA for food additives (food contact notifications or food additive master files).
- Provide expert interpretation of 21 CFR regulations that apply to Food Contact Materials.
Advocacy Services
- Engage Dow Government Affairs on products of interest and advocate for improvements to rules requirements management systems data requests etc.
- Participate in FDA-related trade association committees activities etc.
Required qualifications:
- A minimum of a Bachelors degree is required; Chemistry or other Science/Engineering degree
- 5 years of experience in EH&S Product Safety or Quality
- Basic knowledge of country product-related regulations and compliance requirements
- Able to work in a globally diverse team
- A minimum requirement for this U.S. based position is the ability to work legally in the United States. No visa sponsorship/support is available for this position including for any type of U.S. permanent residency (green card) process.
Preferred Qualifications:
- Project management skills are an asset
- Knowledge of SAP is highly desired
- Knowledge of Si chemistry is a plus
Your Skills:
- Project Management: Project management is the process of leading the work of a team to achieve goals and meet success criteria at a specified time. The primary challenge of project management is to achieve all of the project goals within the given constraints. This information is usually described in project documentation created at the beginning of the development process. The primary constraints are scope time budget. The secondary challenge is to optimize the allocation of necessary inputs and apply them to meet pre-defined objectives.
- Chemistry: Chemistry is the branch of science that deals with the properties composition and structure of elements and compounds how they can change and the energy that is released or absorbed when they change.
- Leadership: Leadership is the ability of an individual or a group of individuals to influence and guide followers or other members of an organization.
- Regulatory Compliance: Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws policies and regulations. Due to the increasing number of regulations and need for operational transparency organizations are increasingly adopting the use of consolidated and harmonized sets of compliance controls.
- SAP Enterprise Resource Planning (ERP): SAP ERP is an enterprise resource planning software developed by SAP SE. SAP ERP incorporates the key business functions of an organization.
- Risk Management: Risk management is the identification evaluation and prioritization of risks followed by coordinated and economical application of resources to minimize monitor and control the probability or impact of unfortunate events or to maximize the realization of opportunities.
- Microsoft office: Microsoft Office or simply Office is a family of client software server software and services developed by Microsoft.
Additional notes:
- Relocation assistance is not available with this position
- Occasional domestic travel (2-3 times annually) to Dow sites several times per year to assist with internal auditing and other domestic travel as needed
Benefits What Dow offers you
We invest in you.
Dow invests in total rewards programs to help you manage all aspects of you: your pay your health your life your future and your bring your background talent and perspective to work every day. Dow rewards that commitment by investing in your total wellbeing.
Here are just a few highlights of what you would be offered as a Dow employee:
- Equitable and market-competitive base pay and bonus opportunity across our global markets along with locally relevant incentives.
- Benefits and programs to support your physical mental financial and social well-being to help you get the care you you need it.
- Competitive retirement program that may include company-provided benefits savings opportunities financial planning and educational resources to help you achieve your long term financial-goals.
- Employee stock purchase programs (availability varies depending on location).
- Student Debt Retirement Savings Match Program (U.S. only).
- Dow will take the value of monthly student debt payments and apply them as if they are contributions to the Employees Savings Plan (401(k)) helping employees reach the Company match.
- Robust medical and life insurance packages that offer a variety of coverage options to meet your individual needs. Travel insurance is also available in certain countries/locations.
- Opportunities to learn and grow through training and mentoring work experiences community involvement and team building.
- Workplace culture empowering role-based flexibility to maximize personal productivity and balance personal needs.
- Competitive yearly vacation allowance.
- Paid time off for new parents (birthing and non-birthing including adoptive and foster parents).
- Paid time off to care for family members who are sick or injured.
- Paid time off to support volunteering and Employee Resource Groups (ERG) participation.
- Wellbeing Portal for all Dow employees our one-stop shop to promote wellbeing empowering employees to take ownership of their entire wellbeing journey.
- On-site fitness facilities to help stay healthy and active (availability varies depending on location).
- Employee discounts for online shopping cinema tickets gym memberships and more.
- Additionally some of our locations might offer:
- Transportation allowance (availability varies depending on location)
- Meal subsidiaries/vouchers (availability varies depending on location)
- Carbon-neutral transportation incentives e.g. bike to work (availability varies depending on location)
Join our team we can make a difference together.
About Dow
Dow (NYSE: DOW) is one of the worlds leading materials science companies serving customers in high-growth markets such as packaging infrastructure mobility and consumer global breadth asset integration and scale focused innovation leading business positions and commitment to sustainability enable us to achieve profitable growth and help deliver a sustainable future. We operate manufacturing sites in 30countries and employ approximately36000 people. Dow delivered sales of approximately$43 billionin 2024. References to Dow or the Company mean Dow Inc. and its subsidiaries. Learn more about us and our ambition to be the most innovative customer-centric inclusive and sustainable materials science company in the world by visiting.
As part of our dedication to inclusion Dow is committed to equal opportunities in employment. We encourage every employee to bring their whole self to work each day to not only deliver more value but also have a more fulfilling career. Further information regarding Dows equal opportunities is available on .
Dow is an Equal Employment Opportunity employer and is committed to providing opportunities without regard for race color religion sex including pregnancy sexual orientation or gender identity national origin age disability and genetic information including family medical history. We are also committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability you may call us at 1-833-My Dow HR ) and select option 8.Required Experience:
Manager
Employment Type
Full-Time
