Specialist, Regulatory Affairs

Key Responsibilities

• Implement CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance, and defined regulatory strategies.
• Prepare and review information required for the development of regulatory CMC dossiers for commercial products (small molecules/pharma, large molecules/biologicals, etc.).
• Author CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management submissions.
• Review scientific information to assess technical merits and suitability of scientific rationale, ensuring clear presentation and data-supported conclusions.
• Prioritize and execute projects according to project plans, timelines, and schedules.
• Work with cross-functional teams to track and follow up on outstanding documentation.
• Coordinate project status and report to stakeholders using different communication channels.
• Understand job responsibilities and processes of cross-functional teams, manufacturing sites, Quality Assurance, and Quality Control.
• Actively participate in departmental improvement activities, including system modifications and maintenance of standard operating procedures and internal guidelines.

Requirements & Tech Stack

• Demonstrated oral and written communication skills.
• Ability to communicate issues succinctly and logically.
• Strong listening skills.
• Demonstrated understanding of related fields such as pharmaceutical manufacturing, analytical testing, and quality assurance.
• Ability to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders.
• Demonstrated flexibility in responding to changing priorities, multi-tasking, and dealing with unexpected events.
• Effective leadership, communication, and interpersonal skills.
• Advanced knowledge of MS Office.
• Superior attentiveness to detail.

Qualifications

• Prior experience in RA/ QA/ QC system and tools like SAP, Documentum, Veeva, LIMS, Spotfire, Power BI is preferable.
• Prior experience in cross-functional teams, manufacturing sites, Quality Assurance, Quality control departments is preferable.