Senior Regulatory Affairs Specialist Job at L&T Technology Services, Orlando, FL

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  • L&T Technology Services
  • Orlando, FL

Job Description

Responsibilities:

• Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending country guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives and project strategy.

• Create detailed written regulatory plans that can be used to target domestic and international shipment dates.

• Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations.

• Review and approve advertising, promotional items and labeling for regulatory compliance.

• Identify potential regulatory approvals' risks based on changes in regulations, standards country specific issues or other unique characteristics of the project. Work with internal stakeholders (R&D, manufacturing, Market Regulatory Affairs) and external stakeholders (regulatory authorities) to mitigate those risks.

• Communicate application progress to internal stakeholders.

The expected salary range for this position is between $77,500 to $1,50,000 annually. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, base salary of internal peers, prior performance, business line, and geographic/office location.

Job Tags

Worldwide,

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