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Sr. 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 site. 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. The selected individual will join R&D, manufacturing, marketing, business development and sales persons at the San Diego, CA site. This location develops and commercializes high-performance enzymes for use in industrial processes. Senior Regulatory Specialist (1701134) – San Diego, CA You will provide regulatory support to the Director, Biotech Regulatory Center of Expertise to 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 and maintain regulatory submissions, including U.S. Food & Drug Administration (FDA) submissions, Environmental Protection Agency (EPA) submissions, and other international submissions as required
  • Conduct regulatory assessments, reviewing, and approving manufacturing changes as appropriate • Interfacing with Research & Development (R&D) teams to collect relevant information, test reports, and technical discussions for regulatory submissions
  • Monitor changes in international and domestic regulatory compliance issues
  • Maintain regular communication with team members to facilitate international registrations and approvals
  • Assist in the development of new Regulatory Department procedures
  • Model basic process safety rules and regulations on site; understanding safety requirements and their importance (prevention, preparedness, emergency plans, reaction to alarms).
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 5 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
  • Demonstrated experience effectively interacting with regulatory agencies including FDA
  • Demonstrated experience developing, implementing and managing programs in support of regulatory compliance
  • Demonstrated experience working cross functionally, maintaining project focus to meet timelines