Overview

Regulatory Intelligence Specialist Job at Sartorius Stedim Biotech in North Shore NSW

Job Description

As part of the Regulatory Affairs team, the Regulatory Intelligence Specialist will be responsible for searching and obtaining regulatory intelligence in all key regulatory areas for Sartorius. These regulatory areas include medical devices and IVD devices, pharmaceuticals and biopharmaceuticals, food and water as well as environmental regulations along with regulations of new regulatory areas which maybe applicable to Sartorius. The Regulatory Intelligence Specialist collects, analyses and interprets regulatory information which will be regularly be presented across departments and to senior management to optimize regulatory strategy and decision making.

As part of the Regulatory Affairs team, the Regulatory Intelligence Specialist will be responsible for searching and obtaining regulatory intelligence in all key regulatory areas for Sartorius. These regulatory areas include medical devices and IVD devices, pharmaceuticals and biopharmaceuticals, food and water as well as environmental regulations along with regulations of new regulatory areas which maybe applicable to Sartorius.

The Regulatory Intelligence Specialist collects, analyses and interprets regulatory information which will be regularly be presented across departments and to senior management to optimize regulatory strategy and decision making.



Responsibilities:
Research, collect, organize and maintain files on regional and global regulatory intelligence and other related information.

Apply recognized methodologies and tools to conduct intelligence analysis and profiling to identify emerging compliance risks and opportunities.

Disseminate regulatory intelligence in a timely manner, to relevant groups

Part of a cross-functional team that defines and oversees the standardization and implementation of processes to monitor the regulatory environment for changes that may have an impact on Sartorius’s products and goals.

Facilitate and lead presentations and discussions across departments and to senior management, which provide intelligence and analysis on emerging trends and risks.

Promote an intelligence culture that supports a targeted approach to compliance.

Author applicable SOPs as necessary.

Assist or perform other regulatory duties as assigned.

Experience:
Knowledge and a sound understanding of regulatory and compliance functions and purpose.

Sound knowledge in the application intelligence tools and methodologies, preferably in a pharmaceutical/device regulatory environment.

Excellent communications skills (written and oral), able to communicate complex information to a variety of audiences.

Good level of competence in the use of specialized intelligence software.

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 work in a global environment and teams

Proficient knowledge of MS Office, Adobe Reader/Writer.

Willingness to travel for training and projects as required

Driving our future growth requires talented people. Sartorius is a dynamic organization suited to people who want to showcase skills, be recognized for expertise and thrive in a vibrant and innovative environment.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.

Please view equal employment opportunity posters provided by OFCCP here

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We look for employees who would like to grow with us and move the innovative life sciences sector forward. In the process, we focus on agile project work, mutual support within teams and working as equals. Sartorius thrives as a company with people who give their very best every day and who are eager to develop personally and professionally.

Further insights into our world of work can be found here.

About Company

Company: Sartorius Stedim Biotech

Company Location:  North Shore NSW

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About Sartorius Stedim Biotech