SUMMARY:
Responsible for providing or overseeing the analysis, administration, and oversight of varied regulatory policies, programs, and practices; provides feedback and guidance to employees and management, using intermediate to complex professional and technical knowledge of regulatory or related information, requirements and procedures.
ESSENTIAL FUNCTIONS:
- Completes and processes various types of regulatory forms, documents, databases, and related materials and information.
- Provides intermediate to complex analysis, interpretation, and counsel to staff, management, and functional leaders regarding regulatory policies, programs, and practices; involves varied operations.
- Provides various research, feedback, and decisions to resolve management and employee questions and requirements; assists with receiving customer feedback and coordinating resources and responses as required.
- Analyzes and reviews intermediate to complex operations, results, feedback, and related regulatory information on an ongoing to as-needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management.
- Ensures the accuracy of various reports, documents, tests, procedures and operational databases, and related details through audits, queries, and operational reviews; works with teams to resolve discrepancies.
- Assists with developing or participating in a regulatory or cross-functional project or program objectives; receives direction and presents information to management.
- Interprets and applies department policies and procedures and assists with applicable laws, rules, and regulations; receives guidance within these areas as needed.
- Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team.
- Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.
QUALIFICATIONS:
Education and Experience:
Bachelor's degree in chemistry, environmental sciences, operations, or a closely related field; AND two (2) years of regulatory experience, including experience with complex programs or operations; OR an equivalent combination of education, training, and experience.
Required Knowledge and Skills
Required Knowledge:
- Intermediate to complex principles, practices, and techniques of product stewardship and/or regulatory affairs.
- Various understanding of the administration and oversight of product stewardship and/or regulatory affairs programs, policies, and procedures.
- Intermediate to complex methods to resolve product stewardship and/or regulatory affairs problems, questions, and concerns.
- Various understanding of applicable regulatory laws, codes, and regulations.
- Understanding of various testing tools, equipment, and calibration.
- Computer applications and systems related to the work.
- Principles and practices to serving as an effective project team member.
- Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations.
- Correct business English, including spelling, grammar, and punctuation.
Required Skills:
- Performing intermediate to complex professional-level regulatory duties in a variety of assigned areas.
- Overseeing and administering various regulatory functions.
- Training others in policies and procedures related to the work.
- Serving as a team member and the development and management of projects.
- Operating in both a team and individual contributor environment.
- Interpreting, applying, and explaining applicable laws, codes, and regulations.
- Preparing intermediate to complex functionals reports, correspondence, and other written materials.
- Using initiative and independent judgment within established department guidelines.
- Using tact, discretion, and prudence in working with those contacted in the course of the work.
- Performing effective oral presentations to large and small groups across functional peers and the department.
- Contributing effectively to the accomplishment of team or work unit goals, objectives, and activities.
- Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work.
Pace® Life Sciences
Pace® makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace® provides professional services to support their operations.