Manager, Regulatory Affairs

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Job description

Job Description

1. Submissions, development and lifecycle maintenance

• Plans and prepares complex regulatory documents for US and ROW product approvals with minimum supervision.

• Resolves submission problem areas with team.

• Prepares clear and accurate internal and external complex administrative and scientific documents, under minimal supervision.

• Prepares complex expository and technical documents, logically constructed and comprehensive in content.

• Prepares documentation that is complete, accurate, and on time.

• Plans and implements regulatory activities that support lifecycle management.

• Reviews labeling and packaging components to ensure accuracy and compliance with government regulations. Submits product labeling in compliance with legal/regulatory requirements and communicates planned/approved changes with operations, commercial, medical affairs and marketing.

2. Advisory Responsibilities

• Participates in global teams and provides regulatory strategy and guidance to global product development teams.

• Under minimal supervision develops US regulatory filing strategy. Provides regulatory strategy and guidance to global teams. Makes recommendations to shape the global strategy in line with regional/commercial objectives.

• Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness. Works collaboratively with cross-functional team to resolve project issues.

• Has recognized regulatory expertise and extensive knowledge of regulatory requirements and regulations with ability to strategically interpret and communicate requirements.

• Ensures planned device development activities comply with US and global regulatory guidelines, and, in cases where they do not, provide a critical analysis of the risks and issues.

• Ensures that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development and registration.

3. Communications and Business Support:

• Represents department on global project teams.

• Maintains professional relationships within the regulatory groups and with functional areas outside regulatory

• Conveys information on team timelines and status to supervisor

• Delivers presentations within the Company, as required

• Establishes relationships with US colleagues as well as global regulatory team to ensure local RA activities are in line with global business priorities

4. Mentoring Responsibilities:

• Performs peer review of complex regulatory documents.

• Provides leadership and development support to the Regulatory team.

• As appropriate, supervises and ensures training and development for Regulatory staff to ensure execution of all duties in a timely and efficient manner.

5. Process and Organizational Effectiveness

• Take personal responsibility for the Notification of Regulatory activities and related database entry/data accuracy for allocated projects.

• Maintains a performance.

• Ensure roles and responsibilities for external services within a project are clearly defined and documented.

• Proactively resolve issues related to outsourced activities.

• Updates and maintains appropriate SOPs for the departments.

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