It's fun to work in a company where people truly believe in what they are doing!
We are currently looking for an EMEA Regulatory Affairs Manager (hybrid) to join our team in our award-winning business in Lucern, Switzerland. The Regulatory Affairs Manager in the supply chain field plays a crucial role in ensuring that all products and processes comply with relevant regulations and standards.
The EMEA Regulatory Manager, reporting to the Director Regulatory Affairs and to the Director Supply Chain Planning EMEA, provides support to international supply chains/logistics, working closely with Global Trade Compliance, Operations, and Supply Chain. The main objective of the role is to ensure and to maintain regulatory standard throughout Neogen’s product portfolio, by interfacing directly with relevant agencies and/or ministries to achieve and/or maintain revenue streams internationally. Oversight of chemistries and animal by-products in products as well as their components and packaging within Neogen’s portfolio is also the key to success.
The successful individual will have deep working knowledge of EU Regulations; REACh (SVHCs), EU/EMA (IVDs and Medical Devices), ECHA (BPR), and familiarity with global and EU import/export regulations; to include but not limited to RoHs, WEEE, and GHS.
This position will take ownership for the ongoing regulatory affairs in line with global supply chain and regulatory affairs requirements.
At Neogen, we partner with our customers to protect and enhance the world’s level of food and animal safety. By offering a diverse suite of solutions for the food, beverage, animal protein and agriculture industries, we empower our customers to safeguard their brands and create better products. We also have the privilege to partner with companies in the companion and performance animal industries, as well as the fields of life sciences and toxicology.
Neogen is a top performing NASDAQ listed business employing around 2,800 people worldwide. Neogen specialises in solutions for animal and food safety offering a diverse range of products and services for the agriculture, food, and beverage industries.
What you’ll be doing:
- Regulatory Compliance: Ensuring that all products meet local, national, and international regulations. This includes working with regulatory agencies and staying updated on changes in regulations.
- Documentation and Reporting: Preparing and maintaining regulatory documentation, such as licenses, permits, and compliance reports.
- Quality Assurance: Collaborating with quality assurance teams to ensure that products meet quality standards and regulatory requirements.
- Supply Chain Coordination: Overseeing the movement of products through the supply chain to ensure compliance at every stage, from procurement to delivery.
- Risk Management: Identifying and mitigating risks related to regulatory compliance in the supply chain.
- Cross-functional Collaboration: Working with various departments, including R&D, manufacturing, and logistics, to ensure regulatory compliance throughout the product lifecycle. Working knowledge of Regulations related to Animal-derived materials, experience with Animal and Plant Health Agency and TRACES a plus.
- Ensuring raw materials are compliant with relevant with in-country chemical legislation, including but not limited to manufacturing and country of sale.
- Build relationships with government agencies, regulators, and consultants to ensure we capture in-country regulations and reporting requirements in countries in which we do business.
- Efficiently and strategically responding to various agency actions that may include, but is not limited to, new product launch, active ingredient reviews, alleged violations, and changes to pertinent regulations in the EMEA region.
- Identifying proposed regulations or stop gaps that may affect revenue, supply chain, or logistics and develops a proposed plan of action.
- Ensuring all documents, correspondence, and other submissions to authorities are presented in a professional, complete, and accurate manner with demonstrated attention to detail.
- Responsible for maintenance of regulatory documents relevant for international trade in a manner that is consistent with Neogen Regulatory Affairs infrastructure.
- Forms and maintains relationships with internal and external persons, including but not limited to, national and international regulatory authorities, involved in registration functions.
- Works collaboratively with internal and external stakeholders to ensure that goals are met.
- May provide briefings to management on new or evolving chemical regulations.
- Provides technical, research, and problem-solving support to Director of Regulatory Affairs and other Neogen staff.
- Oversee and sustain regulatory data, software, and analytics for GHS compliance and SDS generation.
- Manage software that meets all our business needs (composition data, volume tracking, inventory assessments, identification of prohibited substances) for SDSs to leverage the full suite of Neogen’s business tools to make informed and agile decisions.
- Ability to work independently and troubleshoot regulated supply chain issues on behalf of the company.
- Creating strategies for continued compliance to facilitate business growth (regulatory strategies & testing strategies).
- Ability to communicate complex regulations for non-technical business partners.
- You may be required to travel, up to 15%.
About you:
- You will possess a Bachelor of Science Degree or equivalent qualification within chemistry or a relevant field.
- Proven experience in a similar position and knowledge of Chemical and Animal By-product regulations and trade documentation.
- Previous experience in using regulatory IT systems – TRACES, Lisam Excess or equivalent SDS authorizing software, REACH-IT, R4BP, IUCLID, and Animal and Plant Health Agency Import Permitting
- Customer Service & Professionalism – Professionally and tactfully responds to requests for assistance and service from all internal and external customers. Reacts well under pressure/stress and accepts responsibility for own actions. Meets commitments, works effectively with others, and builds and maintains effective working relationships. At all times, must maintain a professional demeanour, tone, and appearance.
- Confidentiality & Ethics – Can maintain confidentiality regarding all work-related activities. Always acts in the best interest of the company in accordance with company policies. Treats all people with dignity and respect and works with integrity. Ability to discern when supervisor needs to be brought in on information which may be beyond the immediate scope of the product manager’s job but needs elevated awareness.
- Problem Solving – Can identify and solve problems in a timely manner. Ability to proactively seek and recommend alternative solutions when appropriate, gather and analyse information, work well with group problem-solving, and use rational and measured reasoning even with dealing with emotional topics.
- Oral & Written Communication – Writes clearly and informatively using proper grammar and spelling in all correspondence without use of unnecessary opinion, speaks clearly, listens well and seeks clarification when needed; capable of succinctly articulating responses to questions and is able to participate in group setting.
- Cost Aware - Works within approved budget. Can develop and implement cost saving or avoidance measures. Conserves organizational resources.
- Organizational Support – Will follow and support corporate policies and procedures. Completes necessary administrative tasks correctly and on time. Ability to function as part of a team spread across multiple locations, balance individual and team responsibilities, contribute to building team spirit, enhance communication across team, help meet team objectives, and assist others in meeting goals.
- Judgment – Ability to demonstrate good reason, judgment, and exercise sound discretion in decision-making, often with minimal direction.
- Planning/Organizing – Works with Director to prioritize and plans work activities. Can utilize time efficiently. Sets goals and objectives, develops realistic action plans and priorities, and follows up as needed. Capable of meeting and adjusting to sometimes changing deadlines.
- Safety and Security - Observes safety and security procedures, reports potentially unsafe conditions.
A Mission That Matters
Neogen is dedicated to the advancement of human and animal wellbeing through science and technology so we can fuel a brighter future for global food security.
Our culture is comprised of our Purpose and Promise, our Principles and our Values – which guide our everyday decision making. Dreaming big while Inspiring and Innovating, doing the right thing while Acting with Integrity, being solution driven while Delivering On Our Promises, celebrating the talent each person brings while Fostering Optimism and valuing diversity while Cultivating Belonging. It’s our actions aligning with these values that provide a consistent, happy and healthy work environment for our employees.
This is an excellent opportunity to be part of a growing organisation. If this role has caught your attention and you feel it might be good fit for you then please don't hesitate to apply.
#LIRemote
Come Be Part Of A Mission that Matters!From inside the farm gate to our dinner plates, Neogen protects the world’s food supply. Through a variety of animal healthcare products, to food safety solutions for dangerous bacteria, allergens, toxins, drug residues and much more, Neogen is there — and you can be too.