Job Description

Ashland LLC

Are you the kind of person that is always thinking, sketching, seeking, and adjusting? Who needs to understand how things work and then figure out how they can work better? Are you a passionate, tenacious, solver who loves to work with others who share your drive? Are you positive, constructive, and ingenious?

Are you always solving?

Then wed like to meet you and bet youd like to meet us.

Ashland has an exciting opportunity for a Global Regulatory Affairs Director to join our Ashland LLC Life Sciences business at our Wilmington, DE or Bridgewater, NJ locations. This is a very visible, significant role within the Company and the Regulatory Affairs function. This position will report to VP, EHS, Quality & Regulatory and the GM, Life Sciences.

The responsibilities of the position include, but are not limited to, the following:

* Represent Product Regulatory to business leadership of pharmaceutical business segment to develop regulatory goals and objectives in alignment with business strategy while defining regulatory standards and assessing impact to Ashlands commercial activities and operations
* Represent Ashland regarding regulatory advocacy and Industry trade association initiatives such as the International Pharmaceutical Excipients Council, American Association of Pharmaceutical Scientists, Medical Device Manufacturers Association or other relevant organizations, to influence proposed legislation and develop industry positions enabling Ashlands businesses
* Monitor changes in existing regulations and emerging regulatory issues in the pharmaceutical and medical device business segments and interpret legislation and devise solutions to comply, mitigate unacceptable risk and create a competitive advantage for Ashlands businesses
* Lead with the courage and confidence to guide the company towards innovative solutions that leverage a risk-based approach yet deliver ethical decisions and products that are safe, suitable and compliant for their end-use markets
* Conduct regulatory reviews on formulations and compliance analysis for destination countries as a part of Ashlands New Product Introduction (NPI) process for commercializing new products
* Prepare and submit product regulatory registrations to relevant agencies/authorities/organizations as required to support sales and marketing in targeted geography and end-use application
* Engage directly with customers to support their regulatory activities relevant to qualifying and / or registering Ashland supplied ingredients
* Recommend and implement management programs and processes, including practices to support regulatory compliance and risk management activities and monitor program effectiveness for continuous improvement
* Provide strategic regulatory direction working with Business and R&D partners

In order to be qualified for this role, you must possess the following:

* A minimum of a Bachelors degree in biology, chemistry or related science
* Thorough knowledge of product regulations, enforcement and industry practice relevant to the pharmaceutical industry is required. This could include drug, excipient and/or medical device experience
* At least 10 years in Pharmaceutical regulatory affairs knowledge
* Relevant experience working with regulatory agencies such as US FDA, EMA and trade organizations
* At least 5 years experience leading and managing regulatory affairs staff
* Proven involvement leveraging regulatory landscapes for competitive advantages

The following skill sets are preferred by the business unit:

* Master degree or above
* Regulatory certification
* Six Sigma certification

In more than 100 countries, the people of Ashland LLC. (NYSE: ASH) provide the specialty chemicals, technologies and insights to help customers create new and improved products for today and sustainable solutions for tomorrow. Our chemistry is at work every day in a wide variety of markets and applications, including architectural coatings, automotive, construction, energy, personal care and pharmaceutical. Visit www.ashland.com to see the innovations we offer.

At Ashland our vision is to be a leading, global specialty chemicals company whose inspired and engaged employees add value to all we touch. In fact our people, employees, customers and vendors define who we are. They are the driving force behind everything we do.

Not only do we value our customers but we value our employees, and we work to offer them a dynamic and challenging environment. We hold ourselves to high standards at Ashland, and we value integrity and honesty.

Ashland has a history of attracting the best people and keeping them. The reasons are simple: industry competitive salary and benefits, pay-for-performance incentive plans and a diverse work environment where employees feel challenged and valued. People come to Ashland and stay. As a growing Fortune 500 specialty chemicals company, we offer opportunities for development and advancement throughout our global organization. Our values define who we are and what we care about as a company. If you are looking for a relationship with a company instead of simply a job, this may be a great fit.

Ashland is proud to be an Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Gender Identity/Sexual Orientation.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or protected veteran status and will not be discriminated against on the basis of disability. NOTE: We do not accept resumes from external staffing agencies or independent recruiters for any of our openings unless we have a signed recruiting agreement in place to fill a specific position.