Ashland Corporate

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Regulatory Affairs Professional, Pharmaceutical and Medical Devices

Regulatory Affairs Professional, Pharmaceutical and Medical Devices

Requisition # 
2018-7030
# of Openings 
1
Job Locations 
US-NJ-Bridgewater
US-DE-Wilmington
Job Post Information* :  
1/19/2018

More information about this job

Overview

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.

Description

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

  • Navigate the people and processes of our commercial, manufacturing and supply chain organizations as well as the external landscape of regulatory agencies and industry groups to advocate on behalf of Ashland
  • Represent Ashland on selected trade, industry, government, and/or technical organizations, 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 Ashland’s businesses
  • Monitor for changes in regulatory strategy at relevant agencies/authorities to identify potential impact to Ashland pharmaceutical and medical device business segments from emerging regulatory issues
  • Interpret legislation and devise solutions to comply, mitigate unacceptable risk and create a competitive advantage for Ashland’s businesses
  • Define regulatory standards and assess impact to Ashland’s commercial activities and operations

Enable Innovation and Sales

  • Represent Product Regulatory to business leadership of pharmaceutical and medical device business segments to develop regulatory goals and objectives in alignment with business strategy
  • Actively participate with Research & Development (R&D) as a regulatory expert in Ashland’s INNOVA process for developing, piloting and scaling-up new products
  • Conduct regulatory reviews on formulations and compliance analysis for destination countries as a part of Ashland’s 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
  • Develop standard product regulatory statements to provide efficient indirect support to customers on frequently requested regulatory topics

Governance and Continual Improvement

  • 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
  • Monitor regulatory activity and assess business impact to identify non-compliance issues or risks
  • Engage and collaborate with internal and external legal counsel on matters of non-compliance
  • Recommend and implement management programs and processes, including practices to support regulatory compliance and risk management activities
  • Monitor program effectiveness and continually improve performance

**This job is based on a ladder structure and the job level (salary) will be determined by the quantity and quality of your experience.

Qualifications

• 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.

C-ASH

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.

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