Regulatory Affairs Manager at Hamilton Lloyd and Associates

Job Summary

• The Regulatory Affairs Manager shall contribute to the company regulatory strategies and content plans.
• The primary responsibility is to support the day-to-day regulatory affairs operations within the regulatory affairs business field and will plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

Job Responsibilities

• Responsible for interpreting regulatory requirements and determining strategy to obtain registrations. Independently make decisions regarding work processes or operational plans and schedules in order to achieve department and project objectives.
• Represent the company to regulatory agencies and interact with Health ministry personnel to expedite pending applications, resolve regulatory matters and manage development meetings for regulatory submissions.
• Provide guidance to business partners regarding regulatory requirements including indications of risk and approximate timing for approvals for planning purposes. Supports both new product development and currently marketed product portfolio within the TM Business Field.
• Independently execute activities related to maintaining compliant regulatory status for marketed products including annual reporting, change management, labeling review, etc.
• Develop and maintain standard operating procedures or local working practices.
• Establish regulatory priorities or budgets and allocate resources and workloads.
• Manage activities such as audits, regulatory agency inspections, or product recalls.
• Participate in the development or implementation of clinical trial protocols.
• Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
• Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
• Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
• Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
• Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
• Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.

Person's Specification
Education:

• A minimum of a Bachelor's degree in a Scientific or related Discipline is required, BSMT is a plus.

Experience:

• Minimum of 10 years' experience in a regulated Medical Device or Pharmaceuticals Industry Required, IVD and/or biologics Industry experience preferred.
• A minimum of 5 years' experience developing and executing Regulatory strategies for complex and/or BLA development programs is required.

Additional Requirements:

• Good organizational skills and an ability to manage multiple tasks/projects/priorities and complex systems simultaneously are required.
• The ability to demonstrate model behavior, understands priorities and encourages others to drive for results will be needed