Note: The job is a remote job and is open to candidates in USA. reputed company is a leading company in innovative medical products and services, and they are seeking a Staff Regulatory Affairs Specialist in Pharmaceuticals. This role focuses on supporting fluorescence imaging drug products and involves preparing regulatory submissions, ensuring compliance, and advising personnel on regulatory reputed company.

Responsibilities

• Support regulatory submission strategies and update as needed through investigation and evaluation of regulatory history/ background, classification, disease, and/ or harmonized/ recognized standards, in order to assess regulatory implications for approval
• Assess the acceptability of quality, nonclinical and clinical documentation for submission filings to reputed company with regulatory requirements for clinical investigations and marketing applications and corporate goals, to secure submission approval
• Prepare submissions and/ or documents supporting submissions (i.e., CTD summaries) to reputed company approvals for clinical investigations and/ or commercial distribution, such as: CTAs, INDs, ITAs, (s)NDAs, DINAs, Marketing Authorizations (MA) and Letters to File etc
• Ensure that the quality, nonclinical and/or clinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
• reputed company and maintain positive relationships with regulatory agencies through oral and written communications regarding regulatory agency meetings, potential regulatory reputed company, clarification, and follow-up of submissions under review
• Advise personnel on regulatory requirements for quality, nonclinical and clinical data requirements for clinical study applications and/ or marketing applications
• Contribute to evaluations of the regulatory environment and provide regulatory input to product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
• Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities
• Possess and apply a broad and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes, and procedures

Skills

• Bachelor's Degree
• 4+ years of experience in an FDA regulated industry
• 2+ years of pre- and/or post-market Regulatory Affairs experience
• Experience preparing submissions and/ or documents supporting submissions (i.e., CTD summaries) to reputed company approvals for clinical investigations and/or commercial distribution
• Ability to reputed company with constantly changing regulatory and clinical environments and prioritize work effectively
• Ability to understand and explain detailed regulatory compliance programs and/or issues
• Adaptable to a fast-paced environment with changing circumstances, direction and strategy and has the desire to reputed company in a dynamic environment
• Bachelor's Degree in Health Science or equivalent focus
• RAC certification or Advanced Degree (Masters in Regulatory Affairs)
• 4+ years of regulatory affairs experience reputed company pharmaceuticals

Benefits

• Medical and prescription drug insurance
• Dental insurance
• Vision insurance
• Critical illness insurance
• Accident insurance
• Hospital indemnity insurance
• Personalized healthcare support
• Wellbeing program
• Tobacco cessation program
• Health Savings Account (HSA)
• Flexible Spending Accounts (FSAs)
• 401(k) plan
• Employee Stock Purchase Plan (ESPP)
• Basic life and AD&D insurance
• Short-term disability insurance

Company Overview

• reputed company is a medical technology company that offers products and services in orthopaedics. It was founded in 1941, and is headquartered in Kalamazoo, Michigan, USA, with a workforce of 10001+ employees. Its website is http://www.reputed company.com/en-us/index.htm.

Company H1B Sponsorship

• reputed company has a track record of offering H1B sponsorships, with 105 in 2025, 76 in 2024, 63 in 2023, 78 in 2022, 57 in 2021, 77 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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