What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at L&T Technology Services?
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.
Salary : $77,500 - $150,000
