Sr. Regulatory Affairs Specialist San Diego, CA

Company: BASF
Location: San Diego
Posted on: September 15, 2020

Job Description:

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, age, citizenship, color, religion, sex, marital status, national origin, disability status, gender identity or expression, protected veteran status, or any other characteristic protected by law. Description At BASF, we create chemistry through the power of connected minds. By balancing economic success with environmental protection and social responsibility, we are building a more sustainable future through chemistry. As the world s leading chemical company, we help our customers in nearly every industry meet the current and future needs of society through science and innovation. We provide a challenging and rewarding work environment with a strong emphasis on process safety, as well as the safety of our employees and the communities we operate in and are always working to form the best team especially from within, through an emphasis on lifelong learning and development. And we are constantly striving to become an even better place to work. BASF has been recognized by Forbes Magazine in 2020 as one of America s Best Employers. Come join us on our journey to create solutions for a sustainable future! Sr. Regulatory Affairs Specialist () San Diego, CA Where the Chemistry Happens We are seeking a professional like you to join our team. In this role, you will be responsible for ensuring compliance with all applicable U.S. and international regulations in which the company does business. You will also be responsible for preparing product submission documentation and providing guidance to project teams as it relates to the application of regulatory requirements. Qualifications - BASF recognizes institutions of Higher Education which are accredited by the Council for Higher Education Accreditation or equivalent Formula for Success * Leveraging your education in Biology or a related field, e.g. Molecular Biology, Microbiology, and your experience in Regulatory Affairs (preferably with prior experience in the biotech industry), 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. * Utilizing your experience applying FDA food regulations, food cGMP s, EPA TSCA regulations, and / or NIH Guidelines for research involving rDNA molecules to biotech products, you will conduct regulatory assessments, reviewing, and approving manufacturing changes as appropriate. * Applying your demonstrated experience working cross functionally, maintaining project focus to meet timelines, you will interface with Research & Development (R&D) teams to collect relevant information, test reports, and technical discussions for regulatory submissions. * Effectively interacting with regulatory agencies (including the FDA), you will monitor changes in international and domestic regulatory compliance issues. * Demonstrating your experience in comprehending, interpreting and conveying scientific information, both orally and in writing, to develop a high quality regulatory submission, you will maintain regular communication with team members to facilitate international registrations and approvals. * Your demonstrated experience developing, implementing and managing programs in support of regulatory compliance will be essential as you assist in the development of new Regulatory Department procedures. * Your unwavering commitment to workplace health and safety will be evident as you model basic process safety rules and regulations on site - understanding safety requirements and their importance (prevention, preparedness, emergency plans, reaction to alarms). * Your superior oral and written communication skills will serve you well as you lead meetings with other departments and prepare the necessary documentation for product submissions. 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 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. BASF provides interesting and challenging learning and development opportunities to help you make the most of your talents and your job. Show moreShow less

Keywords: BASF, San Diego , Sr. Regulatory Affairs Specialist San Diego, CA, Other , San Diego, California