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Sr. Regulatory Manager, HPC

1 month ago

Morristown, United States Arxada Full time
Arxada is a global specialty chemicals business that's committed to solving the world's toughest preservation challenges through better science. [With a proud history of innovation dating back more than a century], we aim to help our customers develop more sustainable solutions that protect and maintain the health and wellbeing of people and extend the life of vital infrastructure while working to reduce our and our customers' ecological footprint.

Sustainable preservation is one of our top priorities. We are making significant strategic investments that will not only decrease our own environmental footprint, but also help customers adapt to long-term environmental and social change through the development of cleaner, greener solutions.

Responsible for leading, developing and managing a world-class regulatory team of specialists focused on the North America professional hygiene and home & personal care (HPC) markets. Act as both a leader and a hands-on contributor to deliver business results obtaining/maintaining regulatory product approvals, responding to regulatory challenges, providing effective customer support and ensuring effective support for innovation activities. As a member of the CMC NA Regulatory Leadership Team, provide a high level of expertise and guidance to business leaders on regulatory strategies to optimize the position of products in the market and support a regulatory compliant culture. The role is also responsible for expert external engagement with key customers, industry associations, and industry consortia with co-suppliers and competitors.

Key Responsibilities:
  • Provide expert advice / guidance, directly or indirectly, to support the HPC Business Team.
  • Manage compliance of new product initiatives with regulatory requirements.
  • Co-ordinate with HPC business leaders and Senior Regulatory Assurance leadership to ensure all products are appropriately prioritized.
  • Prioritize key goals, meeting deadlines and commercial/customer support delivery.
  • Support the innovation pipeline and the product development program.
  • Ensure appropriate screening of development candidates and full consideration of regulatory or safety concerns arising from proposed developments or changes to business models.
  • Ensure that R&T is aware of regulatory developments which may impact on the commercial viability of new products and act as a HPC senior regulatory lead for the wider RA function on innovation project teams.
  • Manage the provision and interpretation of regulatory information to both internal and external customers.
  • Manage the development and delivery of assigned parts of the regulatory program whilst providing an efficient service that is responsive to both internal and external customers.
  • Manage defense activities for specified active substances / ingredients under review.
  • Maintain expertise in relevant regulations (e.g., FDA, Personal Care, Canada etc) and, if relevant, a working knowledge for other jurisdictions in order to ensure delivery of a high standard service.
  • Manage and maintain relationships with specified industry trade bodies, industry consortia and regulatory agency officials.
Key Requirements:
  • Degree level or postgraduate in Life Sciences or Chemistry based disciplines.
  • Experience and knowledge of the N American chemicals regulatory framework. Particularly the FDA pharmaceutical regulations covering hygiene and personal care cosmetic products, EPA FIFRA antimicrobials regulations, and with some knowledge of allied regulations (TSCA, Crop Pesticide Products).
  • Good technical understanding of chemistry, efficacy, toxicology, ecotoxicology, environmental fate or risk assessment methodologies.
  • Also, desirable would be experience with a wide range of disinfecting active substances (including in-situ generated substances) as would experience of disinfection in the food & beverage or animal biosecurity industries.
  • Naturally collaborative with a proven ability to partner with, and influence, others at all levels of the organization.
  • Ability to grasp new concepts quickly and to assimilate/evaluate scientific data.
  • Ability to work under pressure and to strict deadlines with attention to detail.
  • Ability to work independently and as part of a team in a matrix organization.
  • Strong influencing/negotiation skills (internally, externally, and often at higher levels).
  • A high level of communication skills (written and oral).


The expected salary range for this role is USD 153,000 to USD 187,000, but specific employee compensation may vary depending on factors including experience, education, training, licensure, certification, location and other job-related, non-discriminatory factors permitted by law.

This role is also eligible to earn a short-term incentive bonus and the following benefits: 401(k) plan, medical, dental, vision, life, and disability insurance, paid time off, paid holidays and paid sick leave.

Arxada has world class offering in two distinct areas:

Microbial Control Solutions (MCS) focuses on threats posed by microorganisms to people and planet through five distinct business lines including Professional Hygiene, Home & Personal Care, Wood Protection, Paints & Coatings and Material Protection.

Nutrition, Care & Environmental (NCE), meanwhile, provides materials used to manufacture composites for electronics, aerospace and other markets, as well as vitamins and nutritional ingredients, chemicals and performance intermediates, and raw materials for a wide range of high-performance applications.

Arxada is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

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