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Senior Regulatory Affairs Specialist -FDA Medical, Cosmetics, Dietary Supplements

Wacker Chemical Corporation USA · Ann Arbor, MI · 1 mo ago
SalesFull-time

About the role

With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future.

Responsibilities

  • Manage Wacker Chemical Corporation’s corporate compliance program for Medical and Drug applications per the requirements of the 21 CFR regulations
  • Refine Wacker’s corporate procedures and strategy regarding FDA compliance toward medical device components, drugs, and healthcare applications
  • Evaluate and respond to incoming internal and external customer product compliance requests
  • Review and assess the chemical composition of Wacker product formulas and incoming raw material chemicals used in medical device, drug, and healthcare applications such as wound care
  • Prepare and submit forms and applications for Wacker FDA Drug and Device Master Files
  • Prepare portions of Drug Master File (DMF) packages, establish project work as needed with outside consultation, and prepare and submit Medical Device Master File (MAF) packages and updates
  • Experience in Natural Health Products, as well as in the process for filing new drug ingredient notifications and the technical data required by the agency, even if the customer is doing the actual filing
  • Awareness of drug facility registration requirements would be useful
  • For medical devices, working knowledge of biocompatibility testing (USP Class VI & ISO 10993) and their applicability to different types of products
  • Recognition of the differences between US and Canadian regulations
  • Work with other departments to ensure compliance to Good Manufacturing (GMP), FDA-CFR, ISO, Responsible Care standards and regulations
  • Interpret FDA regulations and utilize government and 3rd party databases such as the FDA Electronic Submission Gateway (ESG)
  • Familiarity with appropriate FDA cGMP or other applicable guidance such as the USP Good Manufacturing Processes for Bulk Pharmaceutical Excipients and FDA Active Pharmaceutical Ingredient (API) regulatory approval process

Requirements

  • Bachelor of Science Degree in Biology, Chemistry, Toxicology, or Pharmacology
  • Master's Degree is preferred
  • 7+ years of experience preferred
  • Strong organizational and professional skills with extensive knowledge of FDA regulations and reading and interpreting legal documents
  • Knowledge and experience in 21 CFR regulations on Drugs (API, OTC, Excipient), Veterinary products, Medical Devices, and products which can cross categories, like transdermal patches
  • Strong leadership, interpersonal and problem-solving skills
  • Experience working in cross-functional teams
  • Experience working with leadership and team members to ensure a safety, quality, and environmentally conscious culture
  • Experience in polymer chemistry is preferred

Qualifications

WACKER is an equal opportunity employer committed to diversity, equity, inclusion, and sustainability. We are innovators, researchers, and pioneers and we believe that our individual differences are our collective strength. We foster an inclusive environment that promotes individuality, celebrates diversity, and builds cohesive teams. Together, we create exceptional value for our employees, our customers, and our communities by creating a culture of inclusion and equity that enables, empowers, and values our diverse contributions.

Skills

  • Strong organizational and professional skills
  • Extensive knowledge of FDA regulations and reading and interpreting legal documents
  • Knowledge and experience in 21 CFR regulations on Drugs (API, OTC, Excipient), Veterinary products, Medical Devices, and products which can cross categories, like transdermal patches
  • Strong leadership, interpersonal and problem-solving skills
  • Experience working in cross-functional teams
  • Experience working with leadership and team members to ensure a safety, quality, and environmentally conscious culture
  • Experience in polymer chemistry

Benefits

  • Medical, Dental, and Vision Insurance effective day 1
  • Paid Time Off in addition to personal days and holidays
  • Paid parental leave
  • Wellbeing fund
  • Flexible hybrid work arrangements
  • 401(k) with company match
  • Education Assistance Program
  • Career development and advancement opportunities
  • Support for Community Involvement

Pay

Compensation and Incentive plans

Schedule

Flexible hybrid work arrangements

Reference Code

31073

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