[Hiring] Staff Regulatory Affairs Specialist, Pharmaceuticals @Stryker

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description As Staff Regulatory Affairs Specialist, Pharmaceuticals, on the Pre-Market Regulatory team, you will be supporting fluorescence imaging drug products used in combination with the Open and Minimally Invasive Visualization portfolios within the Endoscopy Business.

• Prepare complex submissions pertaining to pharmaceutical product approvals for clinical investigations, commercial distribution and/or new/expanded indications by FDA, Health Canada and other regulatory bodies.
• Assess post-approval changes to determine the regulatory filing category and ensure compliance by completing thorough regulatory assessments.
• Advise personnel on regulatory pathway option(s) and requirements.
• Support presentations to health authorities and any related communications.
• Support regulatory submission strategies and update as needed through investigation and evaluation of regulatory history/background, classification, disease, and/or harmonized/recognized standards.
• Assess the acceptability of quality, nonclinical and clinical documentation for submission filings to comply with regulatory requirements for clinical investigations and marketing applications.
• Prepare submissions and/or documents supporting submissions (i.e., CTD summaries) to gain 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.
• Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding regulatory agency meetings, potential regulatory pathways, 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.

Qualifications

• 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 gain approvals for clinical investigations and/or commercial distribution
• Ability to comply 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

Requirements

• Preferred Bachelor's Degree in Health Science or equivalent focus
• 4+ years of regulatory affairs experience within pharmaceuticals
• RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

Benefits

• $95,700 - $207,400 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
• Travel Percentage: 10%

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