Director of Regulatory Affairs
il y a 2 jours
Kemin Biologics is searching for a Director of Regulatory Affairs & Quality based in EMENA (Europe, Middle East, North Africa) / North America
As a Director of Regulatory Affairs & Quality you will be a strategic leader responsible for overseeing the Intellectual Property & Regulatory Affairs (IPRA) and Quality Management within Kemin’s vaccine business for food producing animals.
We Are Kemin
We are visionaries who see things differently and are inspired by the world around us. We have been dedicated to using applied science to improve the quality of life for over half a century. Committed to feed and food safety, Kemin maintains top-of-the-line manufacturing facilities where over 500 specialty ingredients are made for humans and animals in the global feed and food industries, as well as the health, nutrition, beauty, and textile markets. We provide product solutions and options to customers in more than 120 countries.
A privately held, family-owned and operated company, Kemin has more than 3,000 global employees and operates in 90 countries including manufacturing facilities in Belgium, Brazil, China, India, Italy, Russia, Singapore, South Africa, and the United States.
ResponsibilitiesThis role is critical in driving the company’s growth, ensuring product & manufacturing compliance, and fostering innovation. This position focuses on:
- Leading and managing regulatory processes resulting in marketing authorizations across the globe. You will be guiding a team of local and regional experts enabling market access for our vaccine portfolio.
- Establishing and safeguarding quality standards in both our regulatory and manufacturing processes and facilities.
- Supports initiatives related to licensing, mergers, and acquisitions.
As regulatory innovation head, this position must apply the innovation concept in all processes related to the responsibility area to speed up the time to market, ensuring legislative adherence.
This position is a member of the Kemin Biologics leadership team and reports directly to the Business Unit President.
Intellectual Property and Regulatory Affairs (IPRA) Management:
- Oversee all regulatory affairs-related activities for our vaccine portfolio globally.
- Develop and implement strategies for realizing marketing authorizations in individual markets and regions, aiming for fast and optimal approval routes.
- Identify and protect current intellectual property and guide initiatives to license or acquire new IP.
- Ensure Standard Operating Procedures (SOPs) are up-to-date and capable of meeting future regulatory requirements.
- Regularly review local and international laws and regulations to ensure company compliance and advise management.
- Engage with government and regulatory bodies, participating in relevant meetings and building a network to support product development and registration strategies.
- Establish a global network of external contributors that can assist with dossier submission and regulatory compliance.
- Manage the Process for Regulatory Innovation (PRI) and its reporting, aligning it with the Product Innovation Process (PIP) for new product development and market introduction.
- Collaborate with WW IPRA (Worldwide Intellectual Property and Regulatory Affairs) to manage IP and related legal agreements.
- Administer the Regulatory Affairs (RA) budget and ensure Kemin Biologics’ compliance through contract management and oversight.
Quality Management:
- Responsible for all Quality-related activities and reporting.
- Build and drive a Quality vision and strategic goals aligned with the business unit’s objectives.
- Lead the continuous improvement of Quality Management Systems, including management reviews, complaint handling, CAPA system, change control, internal auditing, and reporting on quality metrics.
- Collaborate with authorities and business partners to achieve quality objectives, certifications, audits, and special projects.
- Establish robust working relationships across Kemin to define and address gaps in Quality Management Systems.
- Work with QA (Quality Assurance) and QC (Quality Control) to establish priorities and objectives, ensuring compliance with regulations and the global Quality Management System.
- Ensure compliance with the comprehensive Quality Plan led by the QA/QC Manager.
- Oversee major audits, including USDA/APHIS and (EU) GMP audits, risk assessment of raw materials, and customer complaint investigations.
Innovation Management:
- Work in close collaboration with R&D on product development to ensure compliance with quality and regulatory requirements, throughout the development of existing or new products, services, and innovations.
- Create a vision for future quality innovation projects based on research and data analysis and align their execution with different departments to achieve operational excellence.
- Communicate with all relevant stakeholders about project updates and next steps.
- Support the Kemin Biologics finance and corporate department to expedite license and merger projects by participating in due diligence teams for acquisitions and licensing.
- A visionary with a veterinary degree, master's degree, and MBA.
- Over 5 years of experience in animal health vaccine manufacturing and regulatory affairs.
- Strong leadership skills and strategic thinking.
- Excellent interpersonal skills and the ability to lead a diverse team.
What’s in it for You:
- A competitive financial package with bonus opportunities and additional benefits.
- Robust health and wellness support, including a global wellness platform and fresh fruit in break areas.
- Continued learning opportunities with tuition reimbursement and corporate university training.
- The chance to give back through service opportunities and corporate partnerships.
Additional Benefits:
- A dynamic work environment that fosters creativity and innovation.
- Opportunities for career advancement and professional growth.
- A culture that values diversity and inclusion, where every voice is heard.
- Access to cutting-edge technology and resources to excel in your role.
- A supportive management team that encourages work-life balance.
Our Commitment to Sustainability:
- At Kemin, we are dedicated to sustainable practices that benefit our planet.
- We invest in renewable energy and waste reduction initiatives.
- Our commitment to sustainability is reflected in every aspect of our operations.
Your Impact:
- Your work will directly contribute to the health and well-being of food-producing animals.
- You will play a key role in ensuring the safety and quality of food supplies worldwide.
- Your expertise will help shape the future of animal health and vaccine development.
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