Regulatory Affairs Manager

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Job description

Responsibilities:

Work closely with regional APAC regulatory team to develop and drive process efficiencies for APAC regulatory submissions.

Support and advise cross-functional teams and communicate APAC regulatory requirements and challenges effectively to meet project needs and company objectives.

Oversee and direct the development of priorities, timelines, receipt of technical information from appropriate sources, and the preparation of regulatory documentation for new products, amendments of approved products, and submissions that support the maintenance of existing licenses.

Support in implementation of policies, procedures, practices, and strategies to facilitate support of in-country product registrations in APAC.

Review and evaluate issues that may create regulatory or business obstacles and propose solutions.

Monitor APAC regulations/guidelines and the impact of changing/evolving regulations on submissions, practices, and procedures, and communicate to appropriate stakeholders.

Manage the performance and career development of direct reports.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear.

The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requirements:

Bachelor's degree required.

5 years direct experience in Regulatory Affairs in a Medical Device Company required.

Knowledge and Skill Requirements/Specialized Courses and/or Training.

Strong interpersonal and communication skills.

Proficient in Microsoft Office.

Ability to work in fast paced environment.

Advanced written communication skills.

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