Job Description
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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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