Senior Regulatory Intelligence Manager

We are currently hiring a Senior Regulatory Intelligence Manager to join our team! In this role you will lead the efforts to gather analyze and disseminate regulatory information and intelligence that impacts Rhos project teams and our clients development programs. You will be a strategic thinker an effective communicator and an expert in regulatory affairs with a broad understanding of pharmaceutical biotechnology and medical device development.

Our Regulatory Team will tell you joining Rho has been one of their best career moves in terms of contentment financial rewards and career growth which is why we have such stability in the group!

Responsibilities

• Monitor and analyze global regulatory developments including new regulations guidelines and enforcement actions in countries and regions of interest for Rhos 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 countrylevel requirements for clinical trial applications and associated clinical trial reporting requirements including pharmacovigilance/safety reporting.
• For new clinical trial and regulatory project proposals and ongoing projects provide regulatory intelligence in support of a range of strategic and operational planning and activities. This includes relevant regulatory intelligence input on feasibility and country selection for our clients global/regional clinical trials as well as regular updates on new information that could impact the strategy and of regulatory integrated product development and clinical trial projects.
• Assess the impact of regulatory changes on new and ongoing projects led by Rhos Commercial and Federal Sectors including but not limited to regulatory strategy submissions and clinical trial projects.
• Upon request 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 for Rhos project teams and our clients.
• As appropriate collaborate with internal stakeholders including Regulatory Strategy Clinical Trial Operations Quality Legal and Sales/Marketing 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.
• Conduct training sessions and workshops to educate Rho teams on regulatory developments and implications for Rho projects.

Qualifications

• University degree is required; advanced degree is 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 (FDA Health Canada EMA MHRA PMDA etc.).
• Strong analytical and problemsolving 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 fastpaced environment.
• Proficiency with regulatory intelligence databases and software tools.

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Remote Work :

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