The Director of Regulatory Compliance (SC&I) will be responsible for overall regulatory compliance and oversight of the environmental, health, safety, and sustainability programs for the Specialty Chemicals & Ingredients (SC&I) business unit at Greenfield Global. This position directly manages the Business Unit EH&S manager and TTB & Product Regulatory Compliance Manager.
This position reports to the EVP and Managing Director of SC&I for Greenfield Global, Inc.
|Duties & Responsibilities|
- Oversee and guide all regulatory, EH&S, and sustainability related activities for the SC&I BU
- Ensure complete compliance with applicable laws, regulations, and policies, and alignment with industry standards. This compliance includes but is not limited to TTB, EPA, FDA, OSHA, DOT, GHS, Process Safety, Hazmat, USDA, etc.
- Ensure all required regulatory/agency reports are transparent, timely and accurately filed
- Systematically evaluate and interpret internal and external business challenges and provide guidance and strategy to meet challenges while maintaining compliance
- Recommend best practices to improve regulatory and compliance posture
- Encourage and create a culture that ensures compliance to all regulatory and safety requirements throughout the organization through employee engagement
- Serve as an advocate for EH&S, helping to create healthier and safer work environments in all areas of our BU
- Responsible for the review, development, and implementation of EH&S guidelines and policies applicable to all BU locations, in collaboration with our corporate team
- Act as point of contact for BU sustainability initiatives
- Applies knowledge of relevant regulations to support full compliance of our products, subject to a variety of federal and state labelling, hazard communication, reporting and/or registration requirements dictated by government agencies
- Responsible for BU’s product compliance program, which covers SDS authoring and distribution, substance classifications, label content, product registrations, transportation compliance (land, water, air), TSCA and REACH compliance, etc. Product compliance spans all phases of development, commercialization and post-market life cycle management
- Monitor external environment (industry, professional associations) for changes in methodologies and tools that would improve the overall effectiveness of compliance
- Monitor regulatory environment for new or amended regulations impacting the BU’s compliance program and its products
- Build relationships with local, state and federal regulatory agencies, perpetuating cooperation, support and business growth
- Build relationships with and create a culture of cooperation and best practices with like departments within the Ireland and Canadian teams
- Represents company in external bodies dealing with standards and/or product regulations at the national/regional/global level
- Partner with the Commercial team to support integration of new business, commercialization of new products, and making existing products compliant for sales in new jurisdictions with different requirements and languages
- Oversee product regulatory compliance including response to customer inquiries, product statements, disclaimers, etc.
- Develop and maintain responsibility for annual regulatory budgets.
- Oversee all local, state and federal regulatory audits, investigations, and inquiries
- Insure all required regulatory reporting is being accurately completed and submitted in timely fashion by all functional groups
- Support all Corporate EH&S and sustainability policies and initiatives
- Participate in NPI (New Product Introductions) providing regulatory and risk/liability input
- Provide regulatory and risk advice and support to leadership of the Specialty Chemicals and Ingredients business unit.
|Skills & Qualifications|
- Bachelor’s Degree in a science or business-related field is required
- 7 years regulatory compliance experience specific to chemicals, food and/or drug industry is highly preferred. Hazmat and GHS trained is desired. FDA, EPA, EH&S experience is desired
- Experience managing multiple locations
- ISO 9001:2015, cGMP (excipients) experience is an asset
- Knowledge of DOT, IMDG, and IATA requirements a plus
- Travel to BU sites for assessments, coaching and support. Travel component is estimated to 10-20%
- Coach, counsel and empower all direct reports to drive excellence and development for future growth
- Excellent interpersonal and team-building skills; demonstrated ability to develop relationships across departments and across Greenfield’s diverse workforce
- Prior experience leading a team in a chemical, food, or pharma manufacturing environment
- Ability to communicate complex topics clearly to people at all levels of the organization
- Demonstrated ability to lead cross-functional teams in problem-solving.