Sr. Regulatory Manager

Gary, IN, 46401, United States

Posted on 05/12/2019


Position Details

Type:

Permanent

Industry:

Manufacturing & Dist / Chemical

Function:

Biotech / R&D / Science

Job Level:

Standard Management (Manager/Supervisor of Staff)

Education:

Bachelor's Degree

Reference ID:

MTR147

The Sr. Regulatory Manager is responsible for providing regulatory support and expertise to help facilitate the global development, manufacturing, selling and shipping of products.

RESPONSIBILITIES:

  • Represent regulatory on cross functional product development and commercialization teams, providing expert guidance on global regulatory requirements, risk assessments and strategies, assuring global compliance.
  • Partner with business leaders on regulatory strategies to optimize the position of products in the market place and support a regulatory compliant culture.
  • Lead the development and implementation of Regulatory strategy, while providing global perspective and direction.
  • Provide guidance and direction for responding to product challenges. Proactively monitor opportunities and threats arising from new regulations and standards.
  • Prepare responses to questions from regulatory authorities, customers, suppliers and certification organizations to address product regulatory issues.
  • Manage the strategic and tactical efforts for the registration of products.
  • Help maintain products with respect to the Global Chemical Inventories.
  • Review the materials and chemistry to ensure global compliance to various regulations.
  • Manage and own all regulatory and compliance activities.
  • Lead development of talent. Establish clear performance expectations, ensuring alignment with business objectives.
  • Advise on regulatory requirements and regulatory impact during New Product Development.
  • Regulatory submissions for domestic or international projects.


CANDIDATE REQUIREMENTS:

  • Bachelor’s in Chemistry, Biology, Toxicology or a related physical science.
  • 5 years Regulatory leadership experience.
  • Experience with direct response to external inspections and audits.
  • Knowledge of global chemical regulations.
  • Excellent networking skills.
  • Strong project management and analytical skills.
  • Excellent problem solving skills and quality improvement techniques.
  • Excellent focus, forward thinking, the ability to manage change, and a commitment to exceed customer expectations.
  • Ability to operate in the technical, management and commercial environments.

The position requires knowledge and understanding of global chemical controls, as well as regulatory requirements for the development, manufacture and sale of chemical products. This position is an excellent opportunity for a self-motivated, detail-oriented individual, able to perform both routine and specialized regulatory activities within a growing company.