Certis Biologicals United States United States
3 months ago
Certis Biologicals is currently seeking a highly motivated individual to join the Regulatory Affairs team as a Regulatory Affairs Manager. The Regulatory Affairs Manager directs US Federal regulatory package/dossier development, product registration, and lifecycle management of all Certis Biologicals products.
Certis Biologicals is a pioneer and world leader in the development, manufacture, and... distribution of biological pesticides. Certis Biologicals is an innovator in neem extracts (azadirachtin and clarified hydrophobic extract of neem oil), Bacillus thuringiensis bioinsecticides, Baculovirus technologies, and pathogenic and pesticidal fungi technologies.
The Regulatory Affairs team is responsible for obtaining and maintaining regulatory approvals for Certis Biologicals line of biopesticides, and works in partnership with Field Development, Marketing and Sales, and others inside and outside the company to support our expanding global biopesticide business. The Regulatory Affairs team secures product approvals in the United States (including the individual States and territories), other NAFTA countries (Canada and Mexico), as well as the rest of the world (Europe, Africa, Middle East, Asia, and Latin America).
The Regulatory Affairs Manager is responsible for oversight, planning, and management of registration submissions with a focus on US Federal product registrations. This includes strategic planning, issue management, product compliance, and legislative tracking as well as overall management of regulatory submissions to meet regulatory and commercial deadlines, ensure freedom to operate, and maintain the highest level of regulatory compliance.
This fast-paced and timeline-driven position is located at Certis Biologicals headquarters in Columbia MD. The position may require domestic travel. The successful candidate must be detail-oriented with exceptional organizational skills and possess extensive expert knowledge of US Federal Pesticide Regulatory Affairs requirements and practices to ensure deadlines and standards are met.
The Regulatory Affairs Manager will collaborate closely with the Director of Regulatory Affairs and business-lead Vice Presidents to develop regulatory strategies to ensure registrations are obtained and maintained to meet business objectives and timelines.
· Creating processes to ensure tracking of the US Federal registrations, communicating approvals to stakeholders, and increasing efficiencies of the submission process
· Providing direction to the business with respect to registration strategies for new and existing products ensuring that Certis Biologicals products comply with the regulations
· Collaborating with the business teams on the identification, implementation, and management of regulatory acceptance and stewardship issues
· Maintaining knowledge of changing US Federal and state regulatory policies and procedures to ensure compliance; assist in disseminating regulations and guidelines with appropriate interpretation
· Planning and executing submissions that ensure timely approval of US Federal product registration in line with Marketing/Sales launch goals
· Developing and writing clear arguments and explanations for new US Federal product registration
· Preparing US Federal applications to maintain/support existing registrations for annual renewals and coordinating and resolving stop sale or other enforcement or product complaint situations with marketing, legal and customer service
· Establishing and building positive relationships and points of contact with US Federal regulatory lead agencies and industry leaders to represent organizational interests and perspectives
· Supporting Commercial Business and Supply Chain in the design, production, and management of labels and formulas for new and existing commercial products
· Collaborating to ensure timely filings of US Federal product registrations, renewals, special assessments, and reporting requirements
Required Education and Skills/Experience:
· Bachelor’s Degree with emphasis in chemistry, biology, agriculture, biotechnology, or related sciences
· Three (3) or more years’ experience dealing directly with US Federal and State pesticide lead regulatory agencies
· Knowledge of FIFRA and 40 CFR Part 150-189 registration requirements
· Demonstrated ability to communicate effectively (both written and oral) including strong interpersonal and facilitation skills to deal effectively and tactfully with people at all levels of management, with the ability to secure action from staff and management in a matrix organization
· Strong results orientation with the ability to think strategically while paying close attention to details
· Strong record of consistently meeting milestones and commitments
· Ability to develop and implement an effective and efficient regulatory submission strategy
· Ability to travel approximately 15% of the time
Desired Education and Skills/Experience:
· Master’s Degree in a scientific field or closely related discipline
· Direct experience with biopesticide products
· Prior experience working in a matrix environment
· Knowledge of required US Federal label elements (signal words, precautionary language, personal protective equipment, and mandatory label language)
· Prior experience analyzing complex, multidisciplinary challenges involving biopesticide regulatory and compliance issues
· Prior experience initiating and implementing technical improvements to drive efficiency and productivity
Certis Biologicals is a leading manufacturer and distributor of a broad line of biopesticide products for specialty agricultural and horticultural markets and the home and garden market. Certis Biologicals products provide valuable solutions by meeting the challenges faced by today’s growers who are seeking sustainable alternatives, resistant pest management and harvest solutions, and low pesticide residues for market flexibility and export accessibility.
Join our team!
Certis Biologicals offers a competitive benefits package to include a 401(k) Retirement Plan, health insurance, vacation, and a performance based annual bonus program. Please send your resume to email@example.com or visit our website at www.certisbio.com
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