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About you and this role:
We have an exciting opportunity within the Product Stewardship organization for an EMEAI Product Stewardship Manager serving as focal point for the Polyethylene Glycol (PEG) product line to be located at Wiesbaden, Milan, Seneffe, Terragona and Terneuzen.
You will be supporting on the pharmaceutical regulatory space acting as EMEAI business consultant for the following activities. You will partner with the Global Pharma Product Stewardship & Regulatory Consultant to assess opportunities and provide strategic advice to the business and training relevant functions. You will support global & regional advocacy efforts, internal and external issues management activities. You will be the EMEAI Product Stewardship & Regulatory Consultant. You will assess and provide input with prioritization of these activities and projects, coach and mentor others on Pharma compliance, EH&S and Product Stewardship
Responsibilities:
Responsible for execution of business Product Stewardship Program.Manage regulatory submittals and reporting requirements (ex., EU CEP, CEP 2.0, ASMF, eCTD preparation & submission etc.)Review, assess and identify impact of EMEAI pharmaceutical regulations and guidance documents (current, new, and proposed)Provide subject matter expertise for risk assessments following the IPEC Significant Change Guide or similar Risk Assessment guidance documentsEnsure accuracy of product safety documents such as Safety Data Sheets, labels, Excipient Information Package (EIP), Site Master File, and Regulatory Data SheetsIn partnership with Product Regulatory Services, engage regulatory officials on products of interest and advocate for improvements to rules, requirements, management systems, data requests, etc.Define supported end-use applications based upon the existing risk assessment data or potential liabilityExpert level of product stewardship knowledge leverageable beyond the region/work group the individual directly supports. Effectively influences customers and clients to partner on EH&S projects (direct interaction)Initiate and conduct high risk, complicated, cross-business, and/or recurrent Business Risk Reviews (BRRs)Conducts and facilitates Risk Based Product CharacterizationEnsures compliance with EMEAI chemical regulations (EU REACH, CLP, UK REACH, Turkish REACH, Eurasian REACH, etc.) as well as market sector specific regulations for assigned productsCoordinate Product and Process Design and Improvement projects that require Product Stewardship expertiseDesign and deliver product stewardship, safe handling, and regulatory training for key internal and external stakeholders (e.g. customers, regional leadership team)Influence business/corporate sustainability goals by engaging with sustainability teamsIdentify and interpret public priority issues impacting product and lead the development and implementation of an effective issue management strategy that includes engaging Government Affairs/Public Policy leaders as needed for guidance and directionEffectively engage with external agencies related to product complianceQualifications
A minimum of a Bachelor's degree is required. Degree disciplines in Chemistry, Engineering, Toxicology, Biology, Industrial Hygiene, or a Specialized EH&S Discipline.Experience supporting pharmaceutical compliance from a product stewardship, regulatory or quality perspectiveExperience with or direct knowledge of the EDQM, ICH guidelines, IPEC excipients guidelines, US FDA, Health Canada, GMP, GDP .Experience with Drug Master File and CEP filing.The position may require travel for support of business activities support and team meetings.A minimum of 5+ years of experience in the chemical or pharmaceutical industryPreferred Skills
Experience in industry associations leading/participating in regulatory panels/task forces related to emerging regulations/initiatives.Good project lead skills.Good product/regulatory/market knowledge.Experience interacting with customers, regulators, certifying bodies, external consultant and experience of working across multiple functions.Demonstration of independence, initiative and drive to coordinate projects ( project lead skill)Good communications skillsAbility to lead and work cross-functionally and cross-regionally in a team-oriented project environmentThorough understanding and expertise related to pharmaceutical and EMEAI Chemicals regulations and complianceAdditional Note
Relocation assistance is not available for this roleBenefits – 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 career. You 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 need...when 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 Group’s (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.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 world’s leading materials science companies, serving customers in high-growth markets such as packaging, infrastructure, mobility and consumer applications. Our 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 31 countries and employ approximately 35,900 people. Dow delivered sales of approximately $45 billion in 2023. 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 www.dow.com.
As part of our dedication to the diversity of our workforce, 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 Dow's equal opportunities is available on www.dow.com.