The ALTANA Group develops and manufactures high-quality, innovative specialty chemical products. With us, you can help shape many important details of the world of the future. Our four divisions BYK, ECKART, ELANTAS, and ACTEGA have set worldwide standards in their markets. Our innovative products enable companies to develop technologies of the future today, technologies that make life easier, safer, and more comfortable. With sales of more than 2 billion euros, we are one of the world‘s most innovative, fastest-growing, and most proﬁtable chemical companies. We currently employ about 6,000 people who have good ideas for the world of the future. Discover your decisive plus for your future. Bringing you many advantages.
BYK Additives & Instruments is one of the world’s leading suppliers in the field of additives and measuring instruments. Around the world, the additives of BYK ensure that coatings and plastics obtain precisely the desired properties and the correct quality.
Regulatory Affairs Manager
Your task structure
Responsible for achieving new substance approvals from government entities; maintaining and communicating regulatory information related to BYK products; liaison between BYK and third parties; coordinator of contract studies for human health toxicology issues; conducting risk characterizations by assessing chemical hazards.
Duties and Responsibilities:
- File new substance notifications
- Manage TSCA Compliance Program
- Analyze and document TSCA polymer exemptions
- Arrange environmental fate and toxicological testing where necessary
- Submit chemical-related reports to governments, third parties, and foreign distributors
- Coordinate and place contract studies for human health toxicity to assess product safety and product registrations
- Review toxicological studies and interpret results for use in GHS classifications and response to customer requests.
- Assessment of toxicological data with regard to regulatory requirements (e.g. REACh, CLP, Food Contact)
- Conduct risk assessment for application domains such as food contact, medical devices, and feed additives
- Conduct risk characterizations by assessing chemical hazards and (potential for) exposure; recommend risk management measures.
- Experience with QSAR Modeling
- Assessment of uses of raw materials and BYK products in view of human exposure
- Participation in national and international committees and industrial trade associations
- Maintenance of toxicological data in SAP
- Support of the BYK’s global regulatory affairs department
Your recipe for success
- Master’s Degree in Toxicology; PhD in Toxicology or Organic Chemistry Preferred
- 7+ years of experience in product safety, regulatory affairs, or new substance notifications
- DABT Certification or Foreign Equivalent Preferred
- Extensive understanding of toxicology
- Extensive understanding of risk assessment preferred
- Extensive knowledge of Organic Chemistry
- PMN Submission Experience Preferred
- High degree of initiative
- Dependable, flexible, cooperative work attitude
- Strong sense of confidentiality
- Good communication skills (written and oral)
- Excellent organizational skills
- Ability to multi-task (time management and planning)
- Responding to customer inquiries in a timely, accurate, and professional manner
- QSAR Modeling
- Organic chemistry
- Chemical control laws and notification requirements for North America (e.g., TSCA , CEPA, FDA)
- Principals of human health toxicology
- Fundamentals of risk assessment
- Broad understanding of Chemical Inventories in North America
- Content of BYK’s chemical substance submissions to government agencies
- SAP applications- data management, queries, downloads; other processes
- Capable of assessing changed information and impact to product regulatory status
- Understands what information is confidential and maintaining it as such
Your spectrum of advantages
In the ALTANA Group, you will work in a unique culture of innovation where the utmost importance is attached to promoting individual ideas and abilities as well as open, trusting interaction.
We invite you to get to know us better and to become part of our team. Discover your career plus in specialty chemistry. Please send us your application, preferably via our jobmarket www.altana.jobs or to: firstname.lastname@example.org
ALTANA AG and its subsidiaries is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Job number: US00306
Legal entity: BYK USA Inc.
Location: Wallingford, CT
Area of operations: Forschung & Entwicklung allgemein