Operational Regulatory Professional

2 days ago

Makati City, National Capital Region, Philippines beBeeRegulatory Full time $90,000 - $120,000

Regulatory Operations Manager

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As a Regulatory Operations Manager, you will play a pivotal role in ensuring the timely and efficient execution of regulatory activities across various portfolios. Your expertise will be instrumental in navigating complex submission strategies, identifying and mitigating risks, and driving business outcomes.

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The ideal candidate will possess a strong background in pharmaceutical regulatory affairs, with experience in managing multiple projects simultaneously, prioritizing tasks effectively, and collaborating with cross-functional teams to achieve shared goals. Your ability to navigate ambiguity, think critically, and provide creative solutions will be essential in addressing emerging challenges and opportunities.

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Key responsibilities include:

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  • Providing regulatory support for simple and complex activities, including initial applications, commercial lifecycle management, tenders, audits, and launch planning.\
  • Acting as a key point of contact for assigned clusters/countries, working closely with strategists and other local stakeholders to ensure seamless collaboration.\
  • Authoring and reviewing local documents, including cover letters, variations, and MA applications, as well as relevant translations.\
  • Collaborating with labeling hubs and clusters to ensure alignment with approved text and supporting launch activities.\
  • Supporting countries/clusters with authoring of simple HA query responses and coordinating with relevant SMEs/functions to address more complex queries.\
  • Representing the RIO function in improvement projects and leading continuous improvement initiatives that impact people, technology, and/or processes within RIO Hubs.\
  • Leading transformation projects in broader GI&PE and GRS, demonstrating expertise in matrix management, risk mitigation, and business acumen.\
  • Developing and maintaining strong relationships with internal stakeholders, including Country Regulatory Strategists, Hub Submission Managers, and Regional Leadership.\
  • Staying up-to-date with country/cluster regulatory requirements and trends, applying knowledge to drive business outcomes and minimize risk.\
  • Continuously improving processes and procedures to ensure efficiency, quality, and compliance.\
  • Collaborating with cross-functional teams to develop and implement effective regulatory strategies, leveraging technical expertise to drive business results.\
  • Identifying and escalating quality and compliance issues or emerging risks detected during portfolio management, providing proactive solutions to mitigate these risks.\
  • Building and maintaining a culture of excellence, encouraging innovation, and fostering a collaborative environment.\\

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