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Regulatory Strategy

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Opus RegulatoryCambridge, MA
Part-time
  • Opus is committed, in accordance with applicable law, to a policy of nondiscrimination and equal opportunity for all employees and qualified applicants.
  • It will not discriminate on the basis of race, color, religious creed, national origin, ancestry, sex, marital status, sexual orientation, age, disability, or as a disabled Veteran, or any other basis protected by law.
  • While Management is responsible for the development of plans, programs, and controls to ensure that our policy is carried out, we expect all employees to provide individual and collective support for equal employment Opportunity at Opus Regulatory.
  • Opus Regulatory will provide reasonable accommodations, in accordance with the regulations of the Americans with Disabilities Act, and State law.
  • Opus Regulatory is committed to offering a comprehensive and competitive total rewards package to recruit and retain talented professionals.
  • Our benefits program offers a broad array of plans to support our workforce physically, financially, and personally.
  • Health & Wellness
  • 401k retirement plan
  • Short-term and long-term disability
  • Quality of Life
  • Paid personal days
  • Most Regulatory Consultant positions offer significant home-based arrangements
  • This summary is an overview of benefits to prospective employees.
  • More extensive information is provided to new employees upon hire.
  • Paid time off, paid holidays and paid personal days are offered to full time employees.
  • The Regulatory Affairs Principal Strategy Consultant is primarily responsible for the daily management of regulatory requirements for one or more drug products, designing and implementing submission strategy, and developing and maintaining relationships with key client staff and regulatory bodies.
  • Act as a key regulatory affairs expert within a client regulatory team, providing expertise on regulatory strategy, process, filing, best practices, etc.
  • in conjunction with client leadership.
  • Create and maintain primary and associated patient labeling, EU Product Information and labeling documents.
  • Ensure the quality and consistency of labeling documents, contributing to the continuous improvement of the client labeling process.
  • Lead or facilitate labeling approval meetings with relevant stakeholders (e.g., Regulatory, Legal, Marketing, Safety, Clinical) and advise teams on strategy, agency regulations, and guidance affecting labeling.
  • Provide support and guidance to regulatory teams on RA requirements for one or more drug products.
  • Maintain advanced knowledge of changing regulatory requirements and advise teams as appropriate.
  • Represent the client regulatory affairs team in other client meetings or workstreams; provide support for ancillary projects.
  • Perform other duties as assigned.
  • Position Types: Full or part-time; salary or hourly
  • Minimum experience: 6+ years pharmaceutical regulatory affairs experience
  • Minimum education: Bachelor’s degree (advanced degree in a science discipline preferred)
  • Extensive regulatory affairs knowledge and familiarity with RA concepts, procedures, practices, methods, and industry standards.
  • Substantial project management skill, with a demonstrated ability in planning, implementing, and executing tasks to meet RA goals.
  • Regulatory submission knowledge, including eCTD and NDA/IND requirements.
  • Steadfast attention to detail; ability to identify and communicate methods for improving existing processes
  • Ability to generate and employ original ideas to address simple and complex problems.
  • Ability to work in an ever-changing pharmaceutical environment.
  • Knowledge of regulatory affairs teams and ability to recognize when leadership is needed.
  • Ability to work collaboratively and direct the work of others toward common goals.
  • Ability to work in an ever-changing pharmaceutical environment and adapt to resource and knowledge gaps in client RA teams
  • Opus Regulatory - Today
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