Regulatory Specialist - North America

Albaugh LLC

$110K — $130K *
Pharmaceuticals & Biotech
11 - 15 years of experience
Job Overview by Ladders

Qualifications

  • Graduate degree in environmental sciences, chemistry, or agriculture-related field
  • 15+ years in agricultural/specialty pesticides regulatory affairs
  • Strong knowledge of EPA and state regulatory processes
  • Experience in managing product registrations and compliance
  • Proven track record in new product development and label preparation

Responsibilities

  • Lead the registration process for products from concept to state registration
  • Submit regulatory studies and data to support product applications
  • Manage study archives and facilitate data sharing with other regions
  • Prepare and submit label and CSF amendments as required
  • Provide regulatory leadership for marketing and supply chain initiatives
  • Mentor team members and aid in their career development
  • Represent Albaugh in industry associations and task forces

Benefits

  • Professional development opportunities
  • Leadership mentoring and career advancement support
  • Engagement in prominent industry associations
  • Collaborative work environment with a focus on innovation
  • Participation in strategic projects at a corporate level
Full Job Description
Position Overview

The Regulatory Lead, North America is located in Raleigh NC and is responsible for supporting the Regulatory Director, North America by leading the product development and registration activities of product registrations in the assigned market segments of North America region. Regulatory Lead, North America will lead assigned regulatory efforts in matters concerning the EPA and State lead agencies and proactively advise management on issues pertaining to current and future product registrations.

Principal Duties & Responsibilities

New Product Development
• Lead the registration process for all assigned products from approval of initial concept to completion of state registration.
• Ensure the submission of required regulatory studies and data to EPA and state regulators in support of new product registration applications, including alternate active ingredient sources and defense of existing registrations.
• Ensure the management and maintenance of study archives and facilitate data sharing with registration teams in other regions when needed.
• Manage the use of contractors as needed for studies, EPA submissions, and state registration (e.g. CA-DPR).
Label/CSF Preparation and Compliance
• Lead the preparation and submission of Label and CSF amendments to EPA as requested by Marketing, Formulation Development or Supply Chain groups.
• Ensure the organization and maintenance of records for historical Label and CSF approvals and submission activity necessary to ensure Printed label and product formulation compliance for Albaugh owned and contracted manufacturing sites.
• Provide regulatory leadership for Marketing and Supply Chain labeling and formulation initiatives as required
Leadership
• Provide leadership in the areas of US EPA submissions, state registrations, labeling, and management of external consulting resource to accomplish Principal Duties and Responsibilities of New Product Development, Label and CSF Preparation and Compliance.
• Participate in routine performance reviews and quantitatively assess performance relative to assigned Albaugh KPIs.
• Serve as a mentor and actively work to advance career development and advancement objectives of team members.
• Provide regulatory leadership and strategic input in special projects as requested by Albaugh management
Industry Associations / Task Forces
• Ensure representation and leadership for Albaugh on assigned Industry Associations, workgroups and active ingredient task forces (e.g. American Seed Trade Association, CropLife America, Chemical Producers and Distributors Association, Joint Glyphosate Task Force, Dicamba Task Force, 2,4-D Task Force)
Budget
• Assist the Regulatory Director, North America in the preparation of the annual regulatory budget and monitor the progress throughout the year, including monthly updates.

Required Education and Experience

A graduate degree, preferably in environmental sciences, chemistry or other agriculture-related discipline.

Minimum of 15 years' experience in agricultural and / or specialty pesticides regulatory affairs & research and development role.

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