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Director, Regulatory Affairs

ILC Dover

This is a Contract position in Frederica, DE posted May 22, 2021.

ILC Dover is a world leader in the innovative design and production of engineered products employing high-performance flexible materials. Since 1947, we have provided engineered solutions to complex customer problems. Initially known for the production of space suits for NASA, we leverage our vast materials, engineering, process, and design experience to create high performance systems for a wide range of industries. ILC Dover is a portfolio company of New Mountain Capital, which acquired the company in February 2020.

Recognized globally for our flexible containment solutions, ILC Dover serves customers in a diverse range of industries, including pharmaceutical and biopharmaceutical manufacturing, personal care, food and beverage, chemical, aerospace, healthcare and government agencies. ILC Dover’s visionary solutions improve efficiency, safeguard workers and product, and prevent disasters. For more information visit ILCDover.com and follow us on LinkedIn.

The Director of Regulatory Affairs will ensure that the organization is compliant with current regulations and ensure visibility to future potential regulatory changes to sustain compliance and best practices. The Director will develop and implement a clear regulatory strategy, processes to guarantee compliance and provide advice to the organization on the regulatory pathway related to manufacturing, product development, operations, and all programs driven by corporate goals and objectives. Where possible the Director will interface directly with compliance organizations through trade groups, symposia, or membership to represent organizational interests in policy development.

Responsibilities:

  • Ensure continued compliance of the organization to all applicable laws and regulations while planning for and keeping current with proposed changes to regulations using a risk-based approach.
  • Oversee all aspects of regulatory filings and post-approval regulatory activities for products under development and already commercialized
    • Manage plans for efficient and timely submission, review, and approval of regulatory filings
  • Provide guidance and advice to senior management to achieve goals related to product development and commercialization, including regulatory timelines
  • Ensure compliance with regulations and guidelines related to regulatory strategy, submissions, advertising, promotion, and reporting
  • Serve as the ILC Dover regulatory lead and point of contact for governmental agencies
  • Partner with Commercial Sales teams to provide regulatory support on business development activities
  • Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure approvals are obtained
  • Oversee the short-term and long-term planning and directing of regulatory activities
  • Manage preparation and communicate regulatory risk assessment to core team, business unit team and senior management; propose mitigation approaches
  • Maintain knowledge of regulatory environment, regulations, and guidance both enacted and predicted.
  • Contribute regulatory perspective as needed on government proposals and external due diligence activities
  • Contribute to the modification, development and implementation of company policies and procedures for regulatory affairs; maintain currency and compliance with regulatory systems and understands external trends
  • Manage and support current regulatory team by mentoring, developing, and creating growth and succession plans

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

Qualifications:

  • Bachelor’s degree in related field required. Master’s degree preferred.
  • 10+ years of directly related experience in Regulatory Affairs and/or Compliance. Highly regulated industry experience preferred.
  • Strong strategic, critical thinking and decision-making skills with the proven ability to problem solve
  • Proven organization and time management skills with the ability to meet deadlines
  • Demonstrated ability to anticipate critical issues and present mitigating options/actions
  • Demonstrated people-leader skills with the ability to evaluate and assess performance
  • Exceptional verbal and written communication skills
  • Strong interpersonal skills with the ability to build strong relationships with C-suite leadership as well as internal and external contacts/stakeholders
  • Knowledge of the manufacturing and operations process as it pertains to life sciences and Pharm-Bio environments
  • Proven experience utilizing standard office equipment and technology including, but not limited to, Microsoft Office Suite, Reporting and Analytics tools, virtual meeting platforms, Electronic Regulatory Submissions, etc.)

As an Equal Opportunity Employer, ILC Dover is committed to a diverse workforce. We offer competitive benefits including medical, dental, life insurance, 401(k), PTO, and more.

Background Check & Drug Screening Required

E-Verify Used

EOE/AA Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran

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