Senior Specialist, Global Regulatory Affairs Project and Document Management

Job Description

We are seeking a motivated individual with a strong background in regulatory affairs and project management to support our cross-functional projects and streamline our regulatory operations processes. As a key member of our team, you will play a crucial role in managing regulatory submissions, maintaining compliance with industry standards, and championing process improvements to enhance the quality and speed of our regulatory operations activities.

In this role, you will have the opportunity to leverage your expertise in regulatory systems and technologies, staying updated on regulatory changes, and communicating relevant updates to our regulatory affairs team. Your leadership and communication skills will be invaluable as you collaborate with various stakeholders to drive excellence in regulatory operations.

Responsibilities:

• Supports cross-functional or departmental projects related to regulatory operations.
• Establish project plans, monitor progress, coordinate resources, and ensure timely completion of project deliverables.
• Supports all aspects of the submission process for regulatory documents to health authorities. This includes assisting with the planning, preparation, publishing, and tracking of regulatory submissions such as new drug applications, marketing authorization applications, amendments, supplements/variations, renewals, and annual reports.
• Ensures the efficient management of regulatory documentation and information to meet internal and external requirements.
• Maintain regulatory systems and technologies to support the operational needs of the regulatory affairs department.
• Be knowledgeable and work in accordance to applicable regulatory requirements, guidelines, and industry standards as well as update regulatory changes and communicate relevant updates to the regulatory affairs team as necessary. They implement and maintain processes to ensure compliance with electronic submission formats and global regulatory standards.
• Identifies opportunities to enhance efficiency and streamline regulatory operations processes. They lead or help lead process improvement initiatives, evaluate existing workflows, and implement best practices to improve the quality, accuracy, and speed of regulatory operations activities.
• Perform regulatory tasks in Veeva system (Alexx Submissions, Registrations and Archive).
• Performs other activities, as requested by management.

Required:

• Bachelor's degree in a relevant scientific field or regulatory affairs.
• Three (3) years of experience in managing regulatory submissions and document management systems such as Veeva Vault and RIMS
• Strong knowledge of regulatory requirements, guidelines, and industry standards related to regulatory operations.
• Familiarity with electronic submission formats and tools (such as eSubmitter and CTD).
• Excellent organizational and time management skills.
• Strong analytical and problem-solving abilities.
• Effective communication and interpersonal skills.
• Leadership experience and the ability to manage and develop a team preferred.
• Project management certifications (e.g., PMP, PRINCE2) preferred.
• Experience as a project manager preferred.

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NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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