What are the responsibilities and job description for the Regulatory Documentation Manager position at Adama?
Regulatory Documentation Manager
Location:
Raleigh - North Carolina - US
Job ID: 25663
With our customers, we Listen. Learn. Deliver.
Guided by the values of the company, we are seeking an experienced Regulatory Documentation Manager to facilitate the preparation, submission and maintenance of documentation supporting US EPA and Canada PMRA registrations.
These documents include cover letters, individual study reports, labels, CSFs, and all other relevant documents. Submissions to the authorities are done electronically with specific requirements, and one go-to person to manage this process for efficiency and consistency will benefit the company long term with organization of digital files. This role is also responsible for maintaining internal global regulatory databases, an essential although time-consuming a laborious task that Federal Registration Managers are currently responsible for.
Our People Promise:
- No Nonsense - We are bold and direct
- High Touch - It's business and it's personal
- Informal - We are approachable at all levels
- Take Initiative - We are free to explore
- Can do - We believe anything is possible
Fundamental Areas of Focus:
- Manage paper and electronic study file, correspondence, and data for North America Regulatory Affairs, (USA and Canada).
- Oversee GLP data and manage archiving of data and submissions. Educate internal teams on US GLP archiving requirements.
- Serve as NA administrator for the regulatory database (Seleya); update Global data base (RegStore) with NA documents.
- Perform searches for public information on known active ingredients using KNOWTIFY and NPIRS in support of regulatory affairs activities upon request.
- Assure compliance with US Environmental Protection Agency (EPA) and Canada Pest Management Regulatory Agency (PMRA) regulations related to formatting and organizing document files in preparation for submission to these regulatory authorities.
- Working with regulatory managers, plan, assist and manage electronic submission packages to EPA and PMRA.
- Collect and synthesize adverse effects incidents and studies to EPA and PMRA in compliance with FIFRA 6(a)(2) Adverse Effects regulations. Serve on the 6(a)(2) review committee.
- Archive regulatory correspondence for data compensation. Maintain Offer-to-Pay letters, incoming and outgoing, and inform internal stakeholders accordingly.
- Manage the process for obtaining international certificates and Gold Seal letters.
- Working with regulatory managers, assist with annual EPA Pesticide Producing Establishment Reporting and associated recordkeeping.
Talent and Knack:
- Productivity/Quality - Ability to produce work product that is thorough and accurate. Role requires high attention to detail.
- Customer Orientation - Determines and fulfills customer needs and expectations.
- Initiative - Recognizes what needs to be done, takes action / initiative and accomplishes results as the situation demands.
- Communication - Speaks, writes, listens, and presents information in a logical and articulate manner appropriate for the audience.
- Organization/Project Management - Plans and schedules work according to changing priorities; designs and maintains effective systems and processes for managing work.
Required Education & Experience:
- A Bachelor’s Degree in science, technical, or legal field
- 3 or more years of relevant work experience in a regulatory environment, or equivalent combination of education and experience.
- Strong proficiency in database management, as well as Word, Excel, Outlook, PowerPoint applications required
- Experience in GLP archiving preferred.
- Ability to read and interpret regulatory guidelines such as PR Notices, 40 CFR and FIFRA.
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