Sr Regulatory Intelligence Specialist (Remote)

Purpose and Scope

With minimal oversight, the Regulatory Intelligence Specialist will manage the compilation of accurate and timely intelligence and support a culture of Regulatory Intelligence at Tolmar by working with stakeholders across departments to evaluate the impact and drive implementation of change actions based on the analysis of intelligence. This will include using and developing appropriate information and intelligence analysis methodologies and processes to support the delivery of the objectives that align with Tolmar's priorities and host regulatory learning opportunities. The Senior Regulatory Specialist will also serve as the Regulatory Affairs department Learning Administrator, overseeing the group's curricula and tracking training completion.

Essential Duties & Responsibilities

• Research, collect, organize and maintain files on regional and global regulatory intelligence and other related information.
• Apply regulatory knowledge to help identify emerging compliance risks and opportunities.
• Initiate Veeva workflows and act as a project manager to ensure implementation of identified actions based on assessors' analysis of intelligence.
• Assist team that defines and oversees the standardization and implementation of systems/processes to monitor the regulatory environment for changes that may have an impact on Tolmar's products and goals.
• Facilitate presentations and discussions to provide intelligence and analysis on emerging trends and risks.
• Promote an intelligence culture that supports a targeted approach to compliance.
• Develop formal process for submitting Tolmar comments to the agency.
• Author applicable SOPs as necessary.
• Maintain the Regulatory Affairs Department's Curricula and training as the Learning Administrator.
• Represent Regulatory Affairs at the Veeva Core Team

• Perform various other duties as assigned.

Knowledge, Skills & Abilities

• Knowledge and a sound understanding of regulatory and compliance functions and purpose.

• Experience with regulatory intelligence tools and methodologies, preferably in a pharmaceutical/device regulatory environment.
• Excellent communication skills - written and oral, able to communicate with credibility and convey complex information to a variety of audiences.
• High level of critical reasoning skills and a well-developed intuition about appropriate

approaches, and risks.

• Ability to work independently and within groups.
• Ability to coordinate information from various internal and external disciplines.
• Ability to understand regulatory and technical concepts and requirements.
• Ability to perform multiple tasks on several projects.
• Ability to follow specific directions and to request instructions for complex tasks.
• Proficient knowledge of MS Office and Adobe Reader/Writer.

Core Values

• The Senior Regulatory Intelligence Specialist is expected to operate within the framework of Tolmar's Core Values:




• Consistently operate with the highest standards of ethics and compliance.
• Take ownership of your actions, success and setbacks.
• Respect each other and understand that honest collaboration is at the heart of our company success.
• Go the extra mile to make things happen.
• Be committed to all we do and the patients we serve.
• Embrace change with enthusiasm.
• Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Education & Experience

• Bachelor's degree in a science discipline with Regulatory knowledge
• Preferred six or more years' experience in the pharmaceutical/biologic industry with regulatory experience.

Working Conditions

• Remote

Compensation and Benefits

Annual Pay Range: $115,000 - $125,000
Bonus Eligible
Benefits information: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.