Senior Regulatory Affairs Specialist

This is a high-profile role in our organization, responsible for monitoring, analyzing and reporting global regulatory developments to ensure timely and compliant product submissions.

• Key Responsibilities:

The successful candidate will be responsible for delivering high-quality regulatory intelligence outputs such as summaries of country-specific requirements, impact assessments, and recommendations on filing strategies. This will involve overseeing regulatory intelligence tools, databases, and processes to ensure effective monitoring, analysis, and communication.

They will also maintain and improve regulatory monitoring systems and evaluate automation or outsourcing opportunities to enhance operational efficiency.

Analyze global regulatory trends to identify cross-market submission requirements and provide strategic input for globally aligned dossier content and filing approaches.

Anticipate and help manage major impending regulatory changes by supporting business readiness initiatives and contributing to enterprise regulatory change management projects.

Build trusted partnerships with Global and Local Regulatory Affairs, Regulatory CMC, Policy teams, and other internal stakeholders to integrate intelligence into regulatory strategy.

Lead or coordinate cross-product regulatory projects and ensure intelligence outputs are actionable and contribute to harmonized global strategies.

Work closely with policy and strategy teams to align intelligence activities with business priorities and advocate for harmonization where needed.

Track progress on intelligence workplans and contribute to the continuous improvement of tools, methodologies, and workflows.

Propose enhancements to regulatory knowledge capture, sharing mechanisms, and content automation strategies.

Participate in lessons-learned reviews and contribute to SOP or template updates supporting intelligence operations.

To succeed in this challenging and rewarding role, you will need to have the following skills and qualifications:

• A deep understanding of global regulatory frameworks and agency expectations across major and emerging markets.
• Proven experience with global regulatory submissions and a strong ability to interpret and synthesize regulatory guidance and requirements.
• Skilled in regulatory analysis, filing strategy development, and cross-market impact assessments.
• Strong project management capabilities to drive multiple intelligence deliverables and regulatory initiatives in parallel.
• Excellent verbal and written communication skills, with the ability to influence cross-functional teams and senior stakeholders without direct authority.
• Experience managing regulatory tools and databases, with an interest in improving systems and applying automation or AI capabilities where feasible.
• Understanding of knowledge management and change management principles in a regulatory context.

We are looking for highly qualified candidates with the following educational backgrounds and work experiences:

• Doctorate degree and 4+ years of related experience
• OR Master's degree and 6+ years of related experience
• OR Bachelor's degree and 8+ years of related experience
• OR Associate's degree and 10+ years of related experience
• OR High school diploma/GED and 12+ years of related experience

Industry experience in biopharmaceutical regulatory affairs, with emphasis on regulatory intelligence, strategy, or policy.

Demonstrated success supporting global submissions and delivering regulatory insights across regions.

Experience with regulatory policy development, external engagement, or advocacy efforts is a plus.

Familiarity with AI/automation tools for regulatory content and data is desirable.