At a glance

Position:Product Stewardship Manager

Primary Location:Wiesbaden (DEU), Germany

Additional Locations: Milan (ITA) Tarragona (ESP) Seneffe (BEL) Terneuzen (NLD) + More - Less

Schedule:Full time

Date Posted:10/21/2024

Job Number:R2055865

Position Type:Regular

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At Dow, we believe in putting people first and we’re 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. We’re 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 you’re looking for a challenge and meaningful role, you’re in the right place.

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 documents

• Ensure accuracy of product safety documents such as Safety Data Sheets, labels, Excipient Information Package (EIP), Site Master File, and Regulatory Data Sheets

• In 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 liability

• Expert 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 Characterization

• Ensures compliance with EMEAI chemical regulations (EU REACH, CLP, UK REACH, Turkish REACH, Eurasian REACH, etc.) as well as market sector specific regulations for assigned products

• Coordinate Product and Process Design and Improvement projects that require Product Stewardship expertise

• Design 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 teams

• Identify 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 direction

• Effectively engage with external agencies related to product compliance

Qualifications

• 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 perspective

• Experience 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 industry

Preferred 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 skills

• Ability to lead and work cross-functionally and cross-regionally in a team-oriented project environment

• Thorough understanding and expertise related to pharmaceutical and EMEAI Chemicals regulations and compliance

Additional Note

• Relocation assistance is not available for this role

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 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.

• 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 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 visitingwww.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 onwww.dow.com.