Regulatory Affair Specialist Responsibilities and Duties

Posted in Job Responsibilities

Contribute to engineering teams to ensure all regulatory supplies and standards followed in product development process and design.

Involve in engineering change order function through engineering and manufacturing document review, release and change.

Coordinate with associates and managers to search critical success factors and develop measurement systems.

Execute regular process improvement methodologies.

Support execution and planning of new programs, projects and services.

Supervise progress and analyze results.

Recommend modifications or other action as suitable.

Involve in regular FDA communications through written correspondence, conference calls and meetings.

Conduct regulatory evaluation for new products and modify to current products to identify apt regulatory pathway to market.

Involve in creating regulatory departmental SOPs, practices and other relevant training documents.

Head initiatives of research regulatory related to clinical as well as non-clinical aspects of drug creation.

Provide summaries equally within and outside regulatory affair department.

Support preparation, editing and review of special parts of all regulatory documents.

Oversee regulatory affair activities within world wide business.

Interact continuously between business, US Food and Drug Administration and Health Ministries of non-US countries agents.

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