Regulatory Affairs Specialist
Regulatory Affairs Specialist
What makes YOU different?
Lonza Specialty Ingredients (LSI) combines technological innovation with world class manufacturing and process excellence. Together, these enable our customers to deliver their discoveries in key areas:
Microbial Control Solutions serves consumer and technical markets by safeguarding resources and peoples’ wellbeing. We are a trusted and innovative supplier of microbial control solutions and chemical technologies used in a wide range of industrial and consumer solutions. Our vast product portfolio of microbial control and chemical technologies offer quality products backed by technical and regulatory expertise, meeting our customers’ current and future needs.
Specialty Chemical Services provides solutions for composite materials and processing additives for technically demanding industries, such as electronics, transportation and aerospace. We also provide performance intermediates & chemicals for many industrial applications, such as agro intermediates, food & feed ingredients, cosmetics, non-current good manufacturing practices (non-cGMP) intermediates, and custom development & manufacturing.
Lonza Specialty Ingredients (LSI) is looking for a Regulatory Affairs Specialist in our Morristown, NJ office to manage regulatory operations and strategies for North America market business, including pre/post registration processes, scientific data development coordination, internal/external communications with trade associations and regulatory authorities. Assist in product safety functions including product‐specific EHS matters, incident reports, SDS/Label review and publications.
Manage and prepare the submission of new product registrations with relevant business groups and Regulatory Assurance leadership. Assist with follow up requests and responses to and from North American regulatory governing agencies.
Manage the data gathering and compilation of studies (toxicology, chemical, efficacy) necessary for the submission and support of registrations in North America and California.
Collaborate and coordinate with Product Safety, Applications Technology, and various Regulatory Assurance team members.
Manage projects to maintain product registrations including label revisions, EPA DCI responses, registration reviews, CSF updates.
Serve on cross functional projects to provide subject matter expertise support to the business.
Prepare and maintain labels ensuring compliance with federal and state mandates.
Work within Regulatory and with Product Safety and Marketing to manage label system with the aim to ensure compliance with labeling requirements.
Provide necessary compliance reports for Government and State agencies as assigned (i.e. EPA pesticide producing establishment, PMRA sales reports, CDPR Mill Tax) Communicate effectively with manager of state registrations on the subject of new/discontinued/canceled product registrations.
Participate or monitor as required in government agency meetings, representing Lonza and the regulatory Assurance department (EPA OPP, California DPR, Canada PMRA)
Travel up to 10% (once travel resumes)
BS in Chemistry/Biology/Toxicology/Regulatory Sciences required, MS or Ph.D preferred
BS 3‐5 years’ experience / MS 2‐4 years’ experience / Ph.D. 1‐3 years’ experience
FIFRA experience required
Able to effectively argue company positions without damaging relationships with regulators
A major part of the heritage of LSI is being able to deliver unique solutions to its customers. Being the driving force behind this approach – listening, asking, understanding to match the right elements in a new way has been an inherent part of our day-to-day business. Always with the goal to enable a competitive advantage for each customer with a specific product, package or solution.
Lonza 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 qualified individual with disability, protected veteran status, or any other characteristic protected by law.