Regulatory Specialist, Biotech Center of Expertise - San Diego, CA

We are BASF, the world’s leading chemical company and the leader in sustainable chemical solutions. BASF Corporation has over 17,000 employees in North America with sales of over $19.4 billion in 2013. Our portfolio ranges from chemicals, plastics, performance products and crop protection to oil and gas. As a reliable partner, BASF creates chemistry to help its customers in virtually all industries to be more successful. Further information on BASF is available on the internet at http://www.basf.com or in the Social Media Newsroom at newsroom.basf.com. Where the Chemistry Happens… We have a great opportunity for a Senior Regulatory Specialist at our San Diego, CA, Biotech Center of Expertise. This location develops and commercializes high-performance enzymes for use in industrial processes. In the enzymes growth field, we conduct research on, for example, enzymes for human and animal nutrition as well as for detergents and cleaners. Enzymes are proteins that act as catalysts to enable or accelerate biological and chemical processes. In 2013, we expanded our technological basis in industrial enzyme technology. Regulatory Specialist (1701208) You will provide regulatory support to the Director, Biotech Regulatory Center of Expertise and ensure compliance with applicable US and international regulations in which the company does business; preparing product submission documentation, and providing guidance to project teams as it relates to application of regulatory requirements. Formula for Success: You Will…
  • Prepare draft and final versions of regulatory submissions to U.S. and International regulatory agencies using knowledge or experience in biotech regulations for substances used in food and industrial processes.
  • Participate on product development teams as assigned.
  • Provide support to Process Development, Manufacturing, QA/QC, and Business Development using knowledge of biotech regulations and food cGMP’s.
  • Summarize technical and safety information in final study reports for regulatory submissions.
  • Assist regulatory team in developing regulatory strategy to ensure high quality and on-time regulatory submissions.
  • Assist in coordinating and maintaining a document control system for pertinent regulatory documents.
Create Your Own Chemistry: What We Offer You… Adding value to our customers begins with adding value to you. You@BASF is the suite of benefits, perks, programs and unique opportunities we offer to support you—the whole you—in all stages of your life and career. With you@BASF, you create your own chemistry. The total rewards that you receive as a BASF employee go way beyond a paycheck. From competitive health and insurance plans, to robust retirement benefits that include company-matching contributions, to making sure you never stop learning, we believe investing in you is investing in our success. Working for a large, global organization, you’ll have a chance to grow professionally and personally, expand your network and build a rewarding and dynamic career. BASFRSR
Ingredients for Success: What We Look for in You…
  • Bachelor’s degree in Biology or related field, e.g. Molecular Biology, Microbiology. MS degree preferred
  • Minimum of 3 years of experience in Regulatory Affairs, preferably with prior experience in the biotech industry
  • Demonstrated experience comprehending, interpreting and conveying scientific information, both orally and in writing, to develop a high quality regulatory submission
  • Experience applying FDA food regulations, food cGMP’s, EPA TSCA regulations, and / or NIH Guidelines for research involving rDNA molecules to biotech products
  • Ability to leverage computer skills to manage complex projects
  • Demonstrated experience working cross functionally
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