BASF Regulatory Affairs Manager (1801761) – Florham Park, NJ in Florham Park, New Jersey

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.

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 as one of America’s Best Employers in 2017. Come join us on our journey to create solutions for a sustainable future!

Where the Chemistry Happens…

The position of the Regulatory Affairs Manager is designed to provide daily support of customer applications, provide guidance to, and help leverage the BASF product portfolio with external customers in Pharma Solutions in North America (US/Canada/Mexico/Central America) and ensure compliance with all regional regulations. The role is seen as a BASF competitive advantage and is meant to be utilized as a proactive sales and marketing resource.

Regulatory Affairs Manager (1801761) – Florham Park, NJ

Formula for Success: You Will…

  • Provide timely regulatory support and solutions to external customers on BASF Pharmaceutical products in North America and internal support to sales colleagues, marketing/product management, and technical service.

  • Support operations/manufacturing sites as needed, including working with the GMP Compliance teams.

  • Ensure compliance of BASF Pharma Ingredients with all regional regulations.

  • Interact with global analytical colleagues on analytical methods, method validation, and analytical resolution to issues that arise.

  • Serve as first point of contact for Regulatory questions in the region and visit customers to discuss regulatory impact on their upcoming projects.

  • Monitor and interpret regional/local regulatory requirements (e.g., guidelines, laws, pharmacopoeias) and communicate within the organization.

  • Support Regulatory Information and strategy development for Regulatory Filings with customers for traditional Excipients and APIs.

  • Represent BASF in local industry trade associations such as IPEC Americas (excipients) to ensure BASF interests are protected in current and future excipient guidelines issued by regional authorities or IPEC Americas.

  • Engage with USP, FDA, and Health Canada.

  • Support excipient GRAS approval and application usage.

  • Champion BASF safety culture and goals

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.

Ingredients for Success: What We Look for in You…

  • Bachelor’s degree in Science or a related technical discipline; advanced degree is preferable

  • Prior experience in pharmaceutical ingredients (supplier or manufacturer) regulatory affairs required

  • Strong written and oral communication, analytical, problem-solving, and organizational skills

  • Ability to work independently and assist internal and external customers.

  • Receptive to change and innovation with the ability to identify areas for improvement.

  • Able to multi-task and maintain a professional approach in a fast-paced business environment

  • Skilled at working within a multi-functional organization with multiple touchpoints.

  • Able to travel up to 25%(domestic and international)

Job: QUMA - Quality Mgmt & Assurance

Organization: G-ENP-Pharma Ingredients

Title: Regulatory Affairs Manager (1801761) – Florham Park, NJ

Location: NJ-Florham Park

Requisition ID: 1801761