Associate Director, Regulatory Affairs & QA – Kemin Chennai

About the job – Associate Director, Regulatory Affairs & QA – Kemin Chennai

Overview

The Associate Director is responsible for developing, employing, and maintaining all regulatory and quality strategies for the Kemin Health business unit globally. This position will lead a global team of regulatory and quality professionals with direct and indirect oversight over state, national and international product registrations, and quality regulations. He/she will set regulatory direction for new and existing products, explore new territories, and keep strong relationships with regulatory agencies and trade organizations to ensure regulatory compliance of global sales into the Human & Health business. In addition, this role is responsible for managing all Quality Assurance (QA)and Food Safety functions for the global business, ensuring that the quality of products are compliant with all relevant regulations and meet the highest standards of excellence.

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.We are a global ingredient manufacturer that strives to sustainably transform the quality of life every day for 80 percent of the world with its products and services.For over half a century, Kemin has been dedicated to using applied science to address industry challenges and offer product solutions to customers in more than 120 countries. Kemin provides ingredients to feed a growing population with its commitment to the quality, safety and efficacy of food, feed and health-related product s to customers in more than 120 countries.Established in 1961, Kemin is a privately held, family-owned-and-operated company with more than 2,800 global employees and operations in 90 countries, including manufacturing facilities in Belgium, Brazil, China, India, Italy, Russia, San Marino, Singapore, South Africa and the United States.

As a Kemin team member, you’ll receive…

A competitive financial package – in addition to your salary, we offer an uncapped bonus opportunity, 401k match program, and paid vacation and holidays.
Robust health and wellness support – we are proud to offer a fitness reimbursement (for your whole family!), an on-site fitness center, restaurant with seasonal fresh food options (and the ability to order food to bring home), and free fresh fruit in break areas- to name a few.
Continued learning opportunities – Kemin offers tuition reimbursement and recently launched a new corporate university with online and in-person training opportunities for growth and development throughout your entire career.
The chance to give back to our world – Through our foundation of servant leadership, we are proud to offer ample service opportunities, including paid time off to do so. Kemin has a valued corporate partnership with both The World Food Programme and Habitat for Humanity, in addition to many local initiatives.
Opportunities to support our valued educators – Kemin is a proud sponsor of the Iowa Governor’s Stem Advisory Council where we fund annual teacher’s awards. In addition, we have a robust internship and externship program, and frequently host student tours.

Responsibilities

Provide leadership for both the Regulatory Affairs and Quality Assurance functions across the global KH business.
Serves as an active member of the KH Leadership team, which includes responsibility for setting and delivering the strategic plan and budget targets for the worldwide business.
Lead and develop a highly engaged team, which involves hiring, coaching, training, and performance management of all team members.
Provide overall guidance, daily management and direction for the business unit RA department and work across business units to support global registration needs for the products marketed and sold by the primary business unit.
Lead regulatory compliance for products; develop and implement innovative regulatory strategies to achieve product registrations on a timely basis to support the business unit needs and work across business units to support global registration needs in a worldwide capacity.
Serve as official Kemin liaison to major regulatory agencies entities, including, but not limited to US FDA, CFIA, SADER, USDA, OMRI, OSHA, etc.
Consistently audit current and new quality programs and processes for improvements and efficiencies. Bring an entrepreneurial spirit to continuous improvement best efforts.
Build a world-class culture of quality excellence across the global team.
Maintain collaborative relationships with all internal stakeholders with Kemin Industries, especially global corporate regulatory and QA/QC teams.
Achieve expeditious approval of ingredients worldwide through effective planning, preparation and execution of high-quality submissions/dossiers.
Ensure completion of all requirements necessary to achieve external certification of facilities. Sets the direction for the specific certifications needed to ensure products are consistently meeting all quality requirements.
Lead the regulatory and quality teams to cooperate with the Sales, R&D, Ops, and all other functions to provide guidance, estimates on costs, and look for approval opportunity for molecules or products under development.
Develop strategies and provides direction to the Product Innovation Process in the development of information essential to successful product formulations and ensuring compliance with existing regulations.
Serves as a change agent to aid in influencing the future regulatory and quality environment.

Qualifications

Advanced degree in Science or Legal field with 7 years of relevant experience is preferred OR Bachelor’s degree plus 10 years of relevant experience in a pharmaceuticals , nutraceuticals, or food ingredient company.
Knowledge and/or skills related to Quality Management Systems; ISO, AIB, HACCP, GMPs.
Must have excellent time management and organization skills, a high energy level, and a sense of commitment and urgency to ensure obligations are met.
Excellence in presenting, influencing, fostering relationships across global cultures
Ability to lead and develop people, previous experience managing people preferred
Experience working with variety of government agencies.
Experience assembling regulatory dossiers which result in approval by the US and/or foreign regulatory authorities.
Strategic and business-impact mindset.
Ability to influence, articulate and propose alternatives to critical decisions without compromising quality and safety