Senior Regulatory Toxicology Consultant (m/f/d)
Location: USA (Eastern or Central time zone)
Immediately | Fulltime
H2 Compliance (“H2”) was founded in 2006 and has established regulatory affairs operations in the EU and US. In 2016, the company was acquired byThe Landbell Group, with a vision to Engineer the Circular Economy.
H2 supports over 300 companies, including EU and US multi-national blue chips and top global pharmaceutical companies with their chemical management program delivery requirements. The primary focus of the H2 Chemical Team has been on Chemical Regulatory Support, specifically for all aspects of REACH (1907/2006). The company has also expanded to providing regulatory support around global chemical control and stewardship laws and GHS implementations through in-house expertise and partnership arrangements. H2’s Environmental Compliance Team provides support for extended producer responsibility (EPR) legislation, and has built programs for restricted substances and product stewardship.
Your responsibilities
As a Senior Regulatory Toxicology Consultant, you would support the delivery of a variety of regulatory and technical programs that are assigned with a focus on product stewardship and sustainability and chemical compliance. The Senior toxicology position is an excellent opportunity for an experienced regulatory professional in a growing technical team with an international client portfolio. The ideal candidate will excel at interacting with multi-national clients in a technical and product-focused capacity, providing hands-on toxicology expertise, with the ability to advise on and interpret toxicological endpoints and studies and how toxicology intersects with key US and other global chemical control regulations. You will directly manage the relationship with a variety of key clients and provide high-level technical and regulatory consultancy services to clients, while helping to grow and drive the business and its strategy.
- You will support the management and delivery of H2 Compliance’s portfolio of regulatory projects, with emphasis on US TSCA and other such North American chemical regulations (e.g., Prop 65) to key Clients. Additional support for other global chemical regulations (e.g., EU REACH and Canadian CEPA) will also be requested, as needed.
- Provision of toxicological advice, testing strategies and technical expert guidance within the context of hazard/risk assessments and classification.
- Manage multiple consultancy projects, including delivering technical solutions and strategic advice, as well as delivery for TSCA PMNs, LVEs, and other such regulatory notifications and/or registration-type functions (e.g., LOREXs, test market applications, etc.).
- Preparation and technical delivery of regulatory documents and deliverable reports for various chemical regulations, as needed.
- Work within a team of professionals to deliver a robust global product safety program, complete chemical product hazard and toxicology risk assessments, and drive value for a diverse portfolio of products and services across a variety of clients.
- Develop and nurture strong relationships with a select number of clients to ensure on-time delivery of work in a proficient manner.
- Use of registration systems, such as e-PMN, CDX, IUCLID, and REACH-IT, as well as in-house software, element1.
- Apply alternative testing strategies (i.e., in vitro & in silico) and new approach methods (NAMs) (e.g., QSAR, read-across, OECD Toolbox) to chemical regulatory compliance projects.
- Explore the application of toxicological hazard and risk assessment to alternatives analysis and green chemistry advisement and in support of other product stewardship service initiatives.
- Contribute to business development efforts within the North American market via development of new technical services for the H2 Compliance portfolio and participation in marketing and sales efforts, as needed.
- Under normal conditions, the expectation is for up to 10% travel annually – mainly domestically with international 1-2 times per year.
Your qualifications
- Toxicological or related field (ecotoxicology, biochemistry, pharmacology, etc.) primary and/or secondary degree highly preferred.
- > 5 years of experience within a chemical regulatory role, with a focus in toxicology, risk assessments, and testing strategies, including alternative testing and new approach methodologies.
- Board certification (DABT) or working towards certification is highly preferred.
- Subject matter expertise in US TSCA, with experience with regulatory submissions, hazard and risk assessment is highly preferred.
- Proficiency in the use of notification and registration systems, such as e-PMN and CDX, IUCLID, Chesar, and REACH IT.
- Ability to analyze, understand, and research regulatory information, data, and issues.
- A proven record of working independently on multiple projects where the communication and decision-making process is crucial, is required.
- Highly organized and willing to take responsibility for client solutions.
- Strong computer literacy, including proficiency with all Microsoft Office products (Word, PowerPoint, Excel, and Outlook).
- An excellent communicator in written and spoken English.
Apply now
Sounds like an opportunity for you? Then we are looking forward to your application! Send your CV, cover letter, your desired salary and earliest possible start date to Ursula Hayes via email at u.hayes@h2compliance.com. Don’t forget to give us your phone number so that we can reach you quickly and easily.
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