Regulatory Affairs Manager
Location
Kenosha, WI
Position Description
Why Choose Us? At Precision Laboratories we create a unique employment experience by combining a strong company culture with a clear plan for growth. Whether you are very experienced or just entering your career, we will create a stimulating and challenging opportunity. You will have a lot of responsibility and accountability in your position, while being supported by both peers and managers. The business knowledge gained from our fast-paced, stimulating environment will add to your learning and expand your capacity to contribute.
Area of Responsibility
The Regulatory Affairs Manager is responsible for navigating complex regulatory landscapes to achieve product registrations mainly in the US and Canada for Tank Mix Adjuvants and nutrition products across the agriculture field. This role would benefit from familiarity with agricultural chemistry, ag regulatory framework and cross-functional collaboration to enable the thorough preparation of technical data, and strategic collaboration with regional consultants to ensure all product compliance and expedite approvals.
Primary Duties & Responsibilities
- Oversee Precision Laboratories agriculture products, spanning from adjuvants to water management and nutrition, directly or through a network of appointed consultants as appropriate.
- Manage in accordance with the Global Technical Manager relationships with regional regulatory consultants (e.g. individual specialists for US, Canada), and act as their main point of contact with the company.
- Collaborate with R&D, Manufacturing, and Marketing to collect all necessary information for product registration, including but not limited to product composition, approved raw material suppliers, full QC analysis and SOP’s, manufacturing methods, final product labels for each region, SDS documents, and efficacy data to support all product claim.
- Updates and maintains regular communication with the Global Technical Manager and the Division’s Technical Regulatory Manager in relation to all relevant regulatory activities.
- Coordinate all analytical testing as required for production registrations as needed.
- Ensure all currently registered products are renewed in a timely manner to avoid lapse in product coverage.
- Technical data review and analysis for all new products to prepare a thorough technical data package for new product submission.
- Write GHS SDS documents for all new products.
- Primary contact for global sales team to collaborate with regarding customer feedback and troubleshooting.
- Prepare technical data package for private label opportunities to assist customer in product registration.
- Coordinate material samples for field trials and arrange trials when needed.
Required Skills
- MS in chemistry, biology, agriculture or engineering.
- 2+ years of industry experience.
- Prior experience with regulatory or product stewardship.
- Knowledge of Organic and Inorganic Chemistry.
- Working knowledge of Surfactant Chemistry.
- Working knowledge of Fertilizer Chemistry.
- Familiarity with data analysis of field trials.
- Familiarity with project management.
- Must have strong organizational skills.
- Excellent technical writing skills.
- Ability to communicate effectively.
- Ability to work well in cross functional groups, as this role will require the individual to collaborate with regulatory consultants, regulatory bodies, marketing, R&D.
- Ability to independently conduct literature review to provide technical support when needed.
Reports To
Global Technical Manager - Agriculture Division
Additional Guidance and Collaboration from
- Technical Manager(s)
- Product Manager(s)
- Regulatory Managers(s)
- External partners
Career Path
The Regulatory Affairs Manager may lead to assignments with the company as
- Regional Regulatory Manager
- Senior Regulatory Manager
Physical Demands & Work Environment
- Work is primarily performed in an indoor office setting with extended periods at a computer sitting or standing.
- Physical effort is needed to move, lift, or carry office equipment or supplies.
- Occasionally lift 10-15 lbs.
- Use of computer keyboard, mouse, calculator, and other office equipment.