Specialist Regulatory Affairs

About the role

We are seeking an experienced Regulatory Affairs Specialist to join our Abbott Rapid Diagnostic Division in Islamabad. The role operates as an individual contributor, applying deep regulatory knowledge to support product compliance and business objectives.

Key responsibilities

• Lead the preparation and submission of product registration dossiers, progress reports, supplements, amendments, and periodic experience reports.
• Interact with regulatory agencies to expedite approvals and serve as the primary liaison throughout the product lifecycle.
• Participate in product planning, regulatory strategy development, risk management, and Chemistry, Manufacturing and Controls (CMC) activities.
• Ensure timely approval of new drugs, biologics, or medical devices and maintain ongoing compliance for marketed products.
• Provide regulatory guidance to marketing, research, and development teams on manufacturing changes, line extensions, labeling, and regulatory interpretations.

Required profile

• Pharm.D. (preferred) with 2‑3 years of relevant regulatory affairs experience.
• Strong analytical and problem‑solving abilities, capable of working independently under limited supervision.
• Excellent communication skills to interact with internal teams and external agencies.

Required skills

• Regulatory submission and product registration expertise.
• Knowledge of Chemistry, Manufacturing and Controls (CMC) processes.
• Risk management in a regulated environment.

What we offer

• Opportunity to work with a leading global diagnostics company.
• Professional growth within a dynamic regulatory affairs team.