Chr. Hansen, Inc. Senior Regulatory Affairs Specialist in Kuala Lumpur, Malaysia
Location: [[mfield2]] Country: [[mfield1]]
Do you want to help improve food and health around the world?
At Chr. Hansen, food and health is at the heart of everything we do and our natural ingredients are consumed by more than 1 billion people every day. As a global market leader in bioscience, we have the opportunity to address important global challenges such as food waste, healthy living and sustainable agriculture and we need the brightest and most passionate people on board to succeed. We strive to include diversity, equality and inclusion into our actions at work on a daily basis. Want to join us?
The team for you to join
Chr. Hansen is seeking a passionate and dedicated professional to join APAC Regulatory Affairs organization. You will be working for a reputable market leader within the culture, probiotics and HMO field. The main focus of the role will be securing market access of ingredients within APAC countries (excl. China, India) and ensuring preparation of dossiers, submissions, tracking and maintenance of all regulatory related activities. This role will give you the opportunity to work across various functions such as Quality, R&D, Supply chain, Marketing and thereby gaining exposure to new areas. This is a sole contributor role.
What would your role look like?
Develop HMO dossiers, supporting execution and advocacy of Chr. Hansen’s Global Regulatory Affairs in defined business area.
Responsible for HMO GMM-related business, including registration of HMOs, internal regulatory support and external support towards customer applications (e.g. compliance assessments, statements, claims)
Be responsible for regulatory pre-assessments of new registrations (including HMOs), and collecting required data and dossiers for feasibility assessments in collaboration with global and local functions.
Manage and prepare necessary documentation for registration that may require coordination across various functions such as Quality, Microbial Analysis, Product Management, etc.
Respond to regulatory inquiries from health authorities.
Contribute to New Product Development (NPD) projects to provide regulatory guidance to ensure compliance and successful business expansions.
Independently support customers on regulatory related queries including preliminary advice on regulatory requirements.
Monitor trends and changes in regulatory landscape within business area and communicate impact assessments within local and global stakeholders.
Actively seek to identify and minimize risks to the business, and alerting the Regulatory Manager
Undertake general duties and/or projects as required by the business and the Regulatory Manager
Ensure that all regulatory tasks are tracked and logged in systems (ie. Salesforce, Sharepoint).
Maintain and compile knowledge base of existing and emerging regulations, standards, or guidance documents relevant for business area.
Who are we looking for?
Candidates with PhD or similar experience/background/degree within biotechnology, genetic engineering/Food Science or equivalent training
Min. 5 years working experience in Regulatory Affairs and exposure to Food regulations
Direct experience in GMM registrations is an added advantage
Direct experience in External Affairs is an added advantage but not a must
Well organized and able to work independently
Excellent interpersonal communication skills
Team player and takes initiative
What we offer you?
At Chr. Hansen, we offer a working opportunity that you can take part in setting the agenda. In each of our 32 global offices, you will be able to experience an agile organization where takes a short way from idea to implementation. We believe that engagement matters. Our inspiring work environment and collaborative culture would allow you to continuously develop both personally and professionally. As a market leader, Chr. Hansen has constantly pioneered science for almost 150 years and expanded into new area for a more sustainable future. Our founder, Christian D. A. Hansen, was a true entrepreneur and his mentality is still very present and valued today. We keep looking for people who can take charge and come up with new ideas to strengthen our team. Join us and take part in making a meaningful difference!
If you need more information?
Read more about a career at Chr. Hansen here: https://www.chr-hansen.com/en/career
Do you know someone?
If this is not the job for you, but you know someone who might fit and be interested, please feel free to share this job link. Thank you for your referral.
About Chr. Hansen
Chr. Hansen is a global, differentiated bioscience company that develops natural ingredient solutions for the food, nutritional, pharmaceutical and agricultural industries. At Chr. Hansen we are uniquely positioned to drive positive change through microbial solutions. We have worked for over 145 years to enable sustainable agriculture, better food and healthier living for more people around the world. Our microbial and fermentation technology platforms, including our broad and relevant collection of around 40,000 microbial strains, have game-changing potential. We have come far on our journey, and delivered strong results, and as we continue to unlock the power of good bacteria through new technologies, there is so much more we can do. Our employees are the driving force enabling us to live our mission to pioneer microbial science to improve food, health and productivity. We work passionately, because we know we can make a difference for people, animals and plants. And ultimately for our planet. Innovating for a sustainable future is part of our culture, our history and our strategy and is embedded in our purpose: to grow a better world. Naturally. At Chr. Hansen we place importance on diversity, equality and inclusion, and we appreciate difference in perspectives. We therefore encourage everybody to apply no matter race, religion, gender, sexual orientation, disability, etc.