The Manager, Regulatory Data Engagement in GRA plays a pivotal role in leading data-driven initiatives and aligning data management practices with regulatory requirements to ensure compliance and support the development of innovative regulatory strategies.
As Manager, Regulatory Data Engagement, you will be responsible for collaborating with cross functional teams, external stakeholders, and regulatory bodies to implement data strategies that support regulatory processes, ensure compliance with regulations, improve efficiency, and facilitate data-driven decisions.
Delivering quality data management services for substances, products, organisations and referentials (SPOR) to power EU regulatory activities.
Must have experience with SPOR - The four SPOR data management services are:
Substance Data Management Services (SMS)
Product Management Services (PMS)
Organization Management Services (OMS)
Referential Management Services (RMS)
The pay rate for this position starts at $70/hr. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
HR@insightglobal.com. The EEOC "Know Your Rights" Poster is available
here.
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https://insightglobal.com/workforce-privacy-policy/ .
At least 5-7 years experience in regulatory affairs or a related field with a focus on data standards and harmonization
Expert knowledge of IDMP regulations and standards
Strong understanding of regulatory frameworks (e.g., FDA, EMA, ICH guidelines) and their impact on data management and strategy
Demonstrated experience in project management and cross-functional collaboration.
Effective communication skills with the ability to engage and influence stakeholders at all levels.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.