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Senior Regulatory Affairs Expert

Requisition ID:  6335
Location: 

Pittsburgh, PA, US, 15275-1112

Business Unit / Group Function:  Material Protection Products
Work Arrangement:  Fully Remote
Level of Experience:  Intermediate

Employee Type: Regular

 

Who we are
 

LANXESS is a leading specialty chemicals company with sales of EUR 6.7 billion in 2023. The company currently has about 12,800 employees in 32 countries. Our core business is the development, manufacturing and marketing of chemical intermediates, additives and consumer protection products. LANXESS is listed in the leading sustainability indices Dow Jones Sustainability Index (DJSI World and Europe) and FTSE4Good. 

We are looking to find diverse and talented people to join our team. Studies have shown that some individuals are less likely to apply if they do not meet 100% of the criteria. We are looking to equalize the gap! If you are excited about this role but your past experiences do not align perfectly with every qualification, we encourage you to apply. We will look to assess your talent against our competencies, values and requirements to get the best organizational fit. You might be the right candidate for this or other roles we have available!

Join our Team!
 

Job Highlights

 

  • Conduct activities including product registrations, registration reviews, and product expansions to align business strategies with EPA regulatory compliance.
  • Interact with government agencies to advance regulatory agenda.
  • Manage regulatory activities in California (e.g., CDPR, SB258, Prop 65).
  • Manage regulatory activities for DIN registrations in Canada.
  • Provide internal support to various functions within the business (Including Marketing, Supply Chain, Technical, and R&D).  Provide support for other regions on demand.
  • Budget capital expenditures.
  • MOC coordination.
  • Oversight of quality assurance (e.g.,. Efficacy test monitoring).
  • Coordinate and manage label review activities.
  • Carry out management and create communication links with marketing and customer relations. 
  • Review marketing material.
  • Comply with training plan in order to acquire/improve new knowledge in the regulatory area and management skills.
  • Develop expertise in FDA regulations (e.g., MoCRA); determine necessary level of engagement.
  • Oversee activities related to Canadian registrations (e.g., PMRA, NNHPD).
  • Support for unplanned activities and general compliance, such as label revisions, customer support, etc.

Requirements

 

  • Bachelor’s Degree or equivalent in Biology, Chemistry, Chemical Biologist Pharmacy, Chemical Engineering or related field. 
  • Working in a regulatory affairs, compliance or product stewardship field with active projects in antimicrobial or biocidal registrations (US/CAN).
  • 5 -10 years of relevant experience.
  • Effective communication, negotiation, good coordination activities, teamwork, collaboration, leadership, personal integrity, project administration, planning. Must be detail oriented, able to work independently and manage time effectively
  • Strong ability to organize and prioritize multiple projects with competing deadlines while working in work in a high paced environment and able to change direction with little effort.
  • Capable of easily and proactively collaborating with the business team, other functions and/or customers. 
  • Deep knowledge of the regulatory activities such as dossier preparation and new product registration and providing support to customers-product registration.
  • Experience in working with regulatory agencies or knowledge of areas of concentration such as: FDA, FIFRA (EPA), NNHPD (Health Canada), PMRA (Health Canada), and/or Pesticides/biocides.  Knowledge of policies and regulatory requirements including procedures and guidelines for registration of biocides by the US EPA, state agencies and Health Canada.
  • Experience with regulatory dossier preparation, biocide product label development, and answering inquiries both from customers and regulatory authorities.
  • This is a fully remote position and will be located in the United States.

 

What we offer you

 

  • Compensation: We offer competitive compensation packages, inclusive of a global bonus program and an individual performance bonus program. Please note, the actual compensation may vary based on geographic location, work experience, education, and skill level.
  • Comprehensive Benefits: We provide a variety of benefits to support your financial security, health and wellbeing including retirement plans, health programs, life insurance and medical care.
  • Work-Life & Flexibility: We support you in maintaining a balance between working hours and personal life. With our global “Xwork” program, we offer flexible working arrangements in all countries in which we operate.
  • Training & Development: We are committed to your professional and personal development and encourage you in the ongoing pursuit of education, training and knowledge through both formal and informal learning.
  • Diversity: LANXESS is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, gender, gender identity, sex, sexual orientation, age, social class, physical ability or attributes, religion, national origin, veteran status and political beliefs.

 

LANXESS has a value-based performance culture. We are seeking a range of human interests, backgrounds, and experiences that can be engaged to achieve respect, ownership, trust, professionalism, integrity and healing across all sectors.  

 
Join the LANXESS team!

 


Job Segment: Regulatory Affairs, Chemical Research, Scientific, Chemical Engineer, QA, Legal, Engineering, Quality

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