Senior Regulatory Intelligence Lead

1 day ago

New London, Connecticut, United States Lifelancer Full time
Senior Regulatory Intelligence Manager

We are seeking a highly skilled Senior Regulatory Intelligence Manager to lead our regulatory intelligence efforts. In this role, you will be responsible for gathering, analyzing, and disseminating regulatory information and intelligence that impacts our project teams and clients' development programs.

Key Responsibilities:

  • Monitor and analyze global regulatory developments, including new regulations, guidelines, and enforcement actions in countries and regions of interest for our business.
  • Establish and maintain a comprehensive database of regulatory intelligence resources and ensure timely dissemination of relevant information to Rho project leads and other key stakeholders.
  • Establish and maintain country-level requirements for clinical trial applications and associated clinical trial reporting requirements, including pharmacovigilance/safety reporting.
  • Provide regulatory intelligence in support of strategic and operational planning and activities, including regulatory strategy submissions and clinical trial projects.
  • Assess the impact of regulatory changes on new and ongoing projects led by Rho's Commercial and Federal Sectors.
  • Prepare detailed reports and briefing documents for Rho project teams and senior management.
  • Provide regulatory intelligence input and support for the preparation of regulatory risk assessments and development of strategies to mitigate potential regulatory risks.
  • Collaborate with internal stakeholders to ensure alignment on compliance initiatives.
  • Advise Rho clients and project teams on regulatory trends and their potential impact on the project and product development strategy.

Qualifications:

  • University degree required; advanced degree preferred.
  • Minimum of 7 years of experience in regulatory affairs with at least 3 years in a regulatory intelligence role.
  • Extensive experience in the pharmaceutical, biotechnology, or medical device industries.
  • Proven track record of successfully managing regulatory intelligence projects and influencing regulatory policy.
  • Indepth knowledge of global regulatory frameworks and guidelines.
  • Strong analytical and problem-solving skills with the ability to interpret complex regulatory information and provide actionable insights.
  • Excellent written and verbal communication skills with the ability to effectively present information to diverse audiences.
  • Strong project management skills and the ability to handle multiple priorities in a fast-paced environment.
  • Proficiency with regulatory intelligence databases and software tools.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.

Please use the below Lifelancer link for job application and quicker response.

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Remote Work: No

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