Regulatory affairs teams play a central role in ensuring medicines are approved, compliant, and sustainable on the market, without slowing innovation. In the pharmaceutical industry, Regulatory Affairs (RA) acts as the bridge between drug companies and health authorities, translating regulatory requirements into practical action across the entire product lifecycle.

Regulatory compliance is a shared, cross-functional responsibility supported by governance frameworks and quality systems. While no single team owns compliance outright, Regulatory Affairs provides the coordination, oversight, and accountability needed to keep products legally on the market. At a high level, Regulatory Affairs teams are responsible for:

  • Securing and maintaining regulatory approvals.
  • Ensuring ongoing compliance with regional and global requirements.
  • Anticipating regulatory change and managing its impact.
  • Acting as the primary interface between the organization and health authorities.

In many pharmaceutical organizations, regulatory intelligence sits within Regulatory Affairs or operates as a dedicated specialist function. In both cases, RA teams execute based on intelligence about regulatory change, using structured surveillance to inform decisions and actions across the business.

Key responsibilities of pharmaceutical regulatory affairs teams

Regulatory affairs teams are involved throughout the entire lifecycle of a pharmaceutical product, from early research through to post-market oversight. Their responsibilities span strategy, execution, compliance, and coordination.

Regulatory strategy and planning

Regulatory Affairs defines the regulatory pathway that determines how and where a product will be developed and approved. This includes:

  • Defining the appropriate pathway, such as NDA, BLA, MAA, or ANDA.
  • Aligning development plans with regional requirements across the US, EU, and global markets.
  • Anticipating regulatory risks and defining mitigation strategies early.
  • Supporting decisions on where to launch first based on regulatory feasibility.
  • At this stage, regulatory intelligence supports RA teams by monitoring evolving guidance, precedent decisions, and regional expectations that may influence strategy.

Submissions and approvals

Regulatory Affairs teams are responsible for preparing, managing, and maintaining regulatory submissions throughout the product lifecycle. Key activities include:

  • Preparing, compiling, and submitting regulatory dossiers, including INDs, NDAs, ANDAs, BLAs, and MAAs.
  • Ensuring submissions meet the requirements of authorities such as the U.S. Food and Drug Administration and the European Medicines Agency.
  • Managing the full submission lifecycle, including responses to questions, deficiencies, and requests for clarification.
  • Timely regulatory intelligence ensures submissions reflect current expectations and reduces the risk of delays or rework.

Regulatory agency liaison

Regulatory Affairs acts as the official point of contact between pharmaceutical companies and regulators such as health authorities. This responsibility includes:

  • Leading meetings, scientific advice sessions, and inspections.
  • Coordinating responses to regulatory queries and information requests.
  • Ensuring consistent, accurate communication with health authorities.

Clear oversight and traceability are critical here, particularly in high-pressure or time-sensitive situations.

Compliance and regulatory intelligence

Ensuring ongoing compliance is a core responsibility of Regulatory Affairs. RA teams are responsible for:

  • Maintaining compliance with laws, guidelines, and standards, including GxP.
  • Monitoring changes issued by bodies such as the International Council for Harmonisation.
  • Translating new regulations into actionable internal guidance.

Without structured surveillance, compliance efforts become reactive rather than proactive. This is where regulatory intelligence becomes essential to daily execution.

Labeling and product information

Once products are approved, Regulatory Affairs ensures that all product information remains accurate and compliant. This includes:

  • Developing and maintaining prescribing information, patient leaflets, and labels.
  • Ensuring claims are accurate, substantiated, and compliant.
  • Managing label changes following new safety data or regulatory updates.
  • Labeling requirements often vary by region, increasing the need for consistent regulatory surveillance.

Lifecycle management

Regulatory Affairs manages post-approval changes and long-term product sustainability. Responsibilities include:

  • Handling post-approval changes such as CMC updates, new indications, and line extensions.
  • Supporting renewals, variations, and global rollouts.
  • Planning regulatory strategies that maximize product longevity and market access.

Risk, safety, and quality support

RA teams work closely with safety and quality functions to manage regulatory risk. This includes:

  • Supporting pharmacovigilance and safety reporting obligations.
  • Contributing to risk management plans.
  • Ensuring regulatory alignment during quality events, inspections, or recalls.

Cross-functional leadership

Regulatory Affairs operates across the organization, working closely with:

  • R&D
  • Clinical teams
  • Quality and GxP functions
  • Manufacturing
  • Legal and commercial teams

This cross-functional role makes timely communication and shared visibility critical.

The consequences of inadequate regulatory surveillance

Regulatory Affairs teams are responsible for compliance management and execution. They are expected to act on regulatory change quickly and consistently, often across multiple products and markets. Without a structured regulatory surveillance solution, RA teams frequently experience:

  • Information overload and fragmented monitoring.
  • Resource constraints and duplicated effort.
  • Delayed responses that increase the risk of non-compliance.

The consequences can include:

  • Compliance failures and regulatory penalties.
  • Delayed submissions and lost launch windows.
  • Missed opportunities due to outdated or overlooked guidance.
  • Inability to assess the impact of regulatory change across products, markets, and workflows.
  • Difficulty balancing surveillance duties with core Regulatory Affairs responsibilities.

By contrast, integrating regulatory intelligence into the organization either directly or through close collaboration with the RI team enables:

  • Proactive compliance through early visibility of regulatory updates.
  • Improved efficiency, allowing RA teams to focus on submissions and approvals.
  • Timely insight into the impact of regulatory change.
  • Reduced risk of fines, delays, and compliance failures.
  • Streamlined collaboration across RA, regulatory intelligence, R&D, quality, safety, and policy teams.

How technology has changed regulatory affairs in pharma

The volume and pace of regulatory change continue to accelerate. Agencies such as the FDA and EMA issue frequent updates across guidance, policy, and enforcement.

Manual tracking methods are no longer sufficient. Without technology, RA teams face delayed communication, fragmented visibility, and strategic blind spots.

Modern Regulatory Affairs teams increasingly rely on software to support regulatory surveillance and response. AI-assisted monitoring helps surface relevant updates quickly, while structured workflows ensure changes are assessed, documented, and acted on consistently.

This approach supports intelligence activation, embedding regulatory intelligence directly into day-to-day workflows rather than leaving it in disconnected dashboards.

How Infodesk helps Regulatory Affairs professionals

Infodesk supports Regulatory Affairs teams by turning regulatory intelligence into structured, auditable action. The Infodesk solution enables RA teams to:

  • Centralize regulatory updates from health authorities, premium content providers, and internal sources.
  • Filter updates by product, region, and topic to focus on what matters most.
  • Track who reviewed an update, when it was shared, and what action was taken.
  • Maintain a complete audit trail to support inspections and compliance reviews.

Infodesk combines AI-enhanced discovery with human validation to ensure accuracy and relevance in high-stakes regulatory environments. Integration with existing tools enables regulatory updates to flow directly into established workflows.

For pharmaceutical businesses operating globally, this structure reduces compliance risk and improves coordination across functions.

Integrated sources, ready to use

To support regulatory intelligence, regulatory affairs, quality, GxP, and safety teams, Infodesk provides coverage from a wide range of global, multinational, and country-specific authorities and organizations that issue regulatory updates impacting life sciences organizations. Our regulatory intelligence spans over 150 countries and more than 300 authorities.

Health authorities and organizations include:

  • WHO, RAPS Regulatory News, TOPRA, ICH, Eur-Lex
  • FDA, EMA, MHRA, BfArM, AIFA, BASG, Swissmedic, Health Canada, PMDA, TGA, and ANVISA

Premium content integrations include:

  • Cortellis
  • Pink Sheet
  • Scrip
  • Endpoints News
  • Tarius (IQVIA), and others

By combining integrated sources, relevance filtering, and full traceability, Infodesk helps Regulatory Affairs teams stay prepared across the full product lifecycle.

To discuss how Infodesk can support your Regulatory Affairs function, book a meeting and speak with the team about your business challenges, team’s pain points and your requirements.