The Senior Regulatory Affairs Manager is responsible for managing all aspects of complex Regulatory Affairs projects from product development to market. This is a highly collaborative role that coordinates registration dossier submissions across a diverse portfolio of crop protection tools and technologies including biopesticides, fertilizers, and biocontrol products.
- Act as project management overseeing the preparation, implementation, communication, and coordination of regulatory projects.
- Serve as the point of contact on assigned projects and perform a variety of highly skilled duties such as: assembling, coordinating, and managing multidisciplinary technical teams.
- Manage registration projects in crop protection according to the US (Federal and State), Canada, Mexico, and international regulatory frameworks.
- Provide regulatory support for clients including the execution of registration strategies.
- Prepare and submit applications to US EPA for registration of new product formulations and new technical products, registration amendments, and notifications.
- Develop technical documents on a variety of scientific and regulatory topics and prepare expert statements.
- Serve as the go-to source of information regarding regulations and guidelines for clients, knoell USA staff, and knoell global colleagues.
- Identify and assist with implementing new business areas and partner with Business Development and Sales colleagues to promote new business opportunities.
- Represent the company at national and international conferences and trade shows.
- Mentor and coordinate training and skill development across the Regulatory Affairs team.
- Other related work as requested
- Degree in biology, natural resources, chemistry, or related discipline
- 10+ years professional experience in the registration of crop protection products in the national or international regulatory context
- Extensive experience managing projects and timelines
- Experience working and communicating with regulatory agencies such at USDA, EPA, and FDA
- Demonstrated attention to detail, organizational skills, and ability to prioritize work
- Excellent communication and presentation skills
- Ability to work across multiple stakeholders
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Excellent written and oral communications skills. Ability to persuade and negotiate for win-win solutions while serving customer needs. Ability to communicate respectfully and effectively with external customers as well as internal customers. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee must frequently lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus. While performing the duties of this job, the employee is regularly required to sit; use hands; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. The employee is frequently required to walk and climb or balance. The employee is occasionally required to stand.
Equal Employment Opportunity
knoell USA is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
Tim Hendricks, PHR
Human Resources Representative
Office: +1-610-558-3001 ext. 113
3070 McCann Farm Drive
Garnet Valley, PA 19060