Title:  Senior Executive, Global Regulatory Strategy and Intelligence

Senior Executive, Global Regulatory Strategy and Intelligence, Regulatory Affairs Strategy

The Senior Executive, Global Regulatory Strategy and Intelligence within Global Regulatory Affairs (GRA), Specialty Business (Brands and Innovative Medicines) will support the collection, analysis, and dissemination of regulatory intelligence to enable informed decision-making for global regulatory strategy. The role will assist in tracking and interpreting regulatory developments, monitoring the competitive landscape, and providing insights through newsletters and reports. This position will work closely with internal stakeholders to ensure awareness of key regulatory trends and strategic implications.

Responsibilities

Regulatory Intelligence & Landscape Analysis:

• Collect and analyze country- and region-specific regulatory intelligence by interacting with internal experts and external sources.
• Work closely with Country SMEs to understand and document local regulatory landscapes.
• Maintain up-to-date knowledge of evolving global regulatory guidelines, policies, and directives.
• Support the preparation of regulatory strategy documents and briefing materials for internal discussions.
• Track submission timelines and ensure compliance with regulatory requirements.

Competitive Intelligence & Monitoring:

• Track and analyze competitor regulatory strategies, approvals, and trends in key therapeutic areas.
• Identify potential regulatory precedents and leverage insights to inform internal decision-making.
• Conduct gap analyses and provide benchmarking data for regulatory strategies.
• Conduct daily monitoring of regulatory updates, policy changes, and industry news from global health authorities (e.g., FDA, EMA, PMDA, NMPA).

• Maintain internal databases and repositories of regulatory intelligence and precedents.

Regulatory Submission & Compliance Support:

• Assist in the preparation, review, and submission of Module 1 components for regulatory filings in various markets.
• Work closely with internal regulatory teams to ensure compliance with country-specific submission requirements.
• Contribute to the regulatory strategy for non-clinical and clinical aspects of both approved and pipeline products.
• Support the assessment of regulatory requirements for non-clinical and clinical study designs.

Qualifications

• Education: Master’s degree in life sciences, pharmacy, pharmacology, chemistry, or a related field.
• Experience: 3-5 years of pharmaceutical/biotechnology industry experience, preferably in regulatory affairs, regulatory intelligence, or competitive intelligence.
• Strong understanding of global regulatory landscapes, health authority guidelines, and approval pathways.
• Experience in Module 1 preparation and non-clinical/clinical regulatory strategy support.
• Ability to analyze and interpret regulatory trends, policy changes, and competitive strategies.
• Strong communication/interpersonal skills to effectively summarize and present regulatory insights.