Ashland LLC has an exciting opportunity for a Regulatory Affairs Professional, Pharmaceuticals and Medical Devices.
**This position can be in Bridgewater, NJ or Wilmington, DE.
Ashland’s Product Regulatory Affairs team applies scientific knowledge and regulatory expertise to develop responsible and sustainable strategies for opening doors to new market opportunities while complying with applicable legislation, mitigating risk to human health, and by advocating to create a competitive advantage for our businesses. We provide practical interpretations for implementation and comprehensive regulatory compliance solutions for our customers to complex problems in today’s evolving regulatory landscape —we are, always solving™.
This position is responsible for leading the product regulatory affairs programs supporting global pharmaceuticals and medical device commercial activities and their related operations. The position requires collaboration with regional product regulatory staff, business partners and internal stakeholders from various functional groups. In addition to providing governance and interpretation for regulatory requirements internally, the position represents Ashland externally to customers, regulatory authorities and trade organizations.
Advocacy and Regulatory Strategy
Enable Innovation and Sales
Governance and Continual Improvement
**This job is based on a ladder structure and the job level (salary) will be determined by the quantity and quality of your experience.
• Bachelor or Master Degree, in chemistry, toxicology, biology or other science discipline
• 5 - 7 years of Product Regulatory relevant experience working with regulatory agencies such as US FDA, Health Canada or Mexico’s COFEPRIS and trade organizations such as the International Pharmaceutical Excipients Council, American Association of Pharmaceutical Scientists, Medical Device Manufacturers Association or other relevant organizations
• Professional regulatory certification preferred
• Thorough knowledge of product regulations, enforcement and industry practice relevant to the pharmaceutical excipient and medical device industries
• Applicants must be authorized to work in the United States
Technical Skills, Knowledge and Abilities
• Fast learner with a flexible style and the ability to adjust to changing business priorities and changing regulatory landscapes
• Responsive and highly accountable: solution-, results- and action-oriented
• Excellent verbal / written communication and interpersonal skills
• Ability to interface with internal and external contacts at all levels
• Excellent organizational and prioritization skills
• Ability to work collaboratively with peers
• Ability to handle multiple tasks / projects simultaneously
• Ability and experience to lead international projects, programs and virtual teams
• Self-starter with ability to think and act independently and to make sound recommendations and decisions
• Demonstrated ability to manage projects across complex organizations
• Good analytical and problem-solving skills
• Must be able to work in a multi-cultural environment
TO APPLY FOR THIS POSITION, please select the Apply button. If no Apply button is provided, please visit Ashland's Career Center. Once there, enter job number 2018-7030 in the Keyword Search field to find this posting and apply on-line.
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.
Ashland Global Holdings Inc. (NYSE: ASH) is a premier global specialty chemicals company serving customers in a wide range of consumer and industrial markets, including adhesives, architectural coatings, automotive, construction, energy, food and beverage, personal care and pharmaceutical. At Ashland, we are 6,000 passionate, tenacious solvers - from renowned scientists and research chemists to talented engineers and plant operators - who thrive on developing practical, innovative and elegant solutions to complex problems for customers in more than 100 countries. Ashland also maintains a controlling interest in Valvoline Inc. (NYSE: VVV), a premium consumer-branded lubricant supplier. Visit ashland.com to learn more.
Ashland. always solving™
We are passionate, tenacious, solvers who thrive on developing practical, innovative and elegant solutions to complex problems in applied chemistry, always pushing the boundaries of what’s possible, and advancing the competitiveness of our customers across diverse industries.
Our people—molecular scientists, chemists, process engineers, logisticians, research scientists, economists, analysts, compliance auditors, salespeople, safety experts and more—are distinguished by their ability to create and apply specialized chemistry in ways that enable customers to amplify the efficacy, refine the usability, add to the allure, ensure the integrity, and improve the profitability of their products and applications.
The Ashland Way
Our vision, mission, way and values are the foundation for what makes Ashland, Ashland. What we aspire to accomplish, how we work every day toward that vision, and the way that we do things are what give substance to the promises we make to each other, customers and investors.
Our vision is to make a better world by providing creative solutions through the application of specialty ingredients and materials.
Our mission is to develop practical, innovative, and elegant solutions to complex problems in applied chemistry, always pushing the boundaries of what’s possible, and advancing the competitiveness of our customers across diverse industries.
Our way is to respect, protect, and advance the people we work with, companies we serve, shareholders who invest in our future, communities we’re a part of, and planet we share.
Ashland is proud to be an Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Gender Identity/Sexual Orientation.
Ashland is proud to be an Equal Opportunity Employer. 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.