05.07.20
Company Name:
Lonza
Company Description:
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Job Title:
Regulatory Associate Specialist
Job Description:
The Regulatory Assurance Specialist will prepare registration packages with various degrees of complexity, for submission to government agencies in North America, supporting existing and new products for both internal and external customers. Will maintain a compliant, cost-effective work environment to advance LSI and CPI business objectives. Need the ability to learn registration processes and procedures as well as how to effectively argue company positions without damaging relationships with regulators. Positive attitude and ability to work with regulators as well as people in the business functions.
Key Responsibilities:
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.
Please click the "APPLY NOW" button below to send your resume!
Lonza
Company Description:
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Job Title:
Regulatory Associate Specialist
Job Description:
The Regulatory Assurance Specialist will prepare registration packages with various degrees of complexity, for submission to government agencies in North America, supporting existing and new products for both internal and external customers. Will maintain a compliant, cost-effective work environment to advance LSI and CPI business objectives. Need the ability to learn registration processes and procedures as well as how to effectively argue company positions without damaging relationships with regulators. Positive attitude and ability to work with regulators as well as people in the business functions.
Key Responsibilities:
- Review graphic labels in comparison with master labels to ensure compliance with Federal mandates.
- Maintain product registration information within the company databases and ensure effective communication to the North American regulatory team.
- Implement Lonza strategy for Lonza Quality Management of supplemental distributors.
- Participate as required in trade association meetings, representing Lonza and the Regulatory Assurance department. (AAPCO, SFIREG, ALSTAR)
- With assistance, prepare the submission of registration applications to North American regulatory governing agencies with relevant business groups and Regulatory Assurance Leadership. Assist with follow-up on requests and responses to and from North American regulatory governing agencies.
- Maintenance of ISO 9001:2015 certifications for the businesses by complying with processes, procedures and instructions for all activities in which this role participates.
- Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
- Experience with FIFRA, EPA and State antimicrobial pesticide regulations are beneficial.
- Perform other duties as assigned.
- University degree in Physical Science is preferred with 1year experience.
- HS Diploma and applicable 3-5 years technical experience will be considered
- Basic understanding of regulated product environment and functions.
- Attention to details, planning, and prioritization skills. Ability to manage numerous projects simultaneously. Good communication skills in speaking and writing. Ability to establish effective and collaborative working relationships with all stakeholders over time.
- Ability to learn registration processes and procedures. Positive attitude and ability to work with internal Regulatory and sales teams.
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.
Please click the "APPLY NOW" button below to send your resume!