Team Lead-Publishing & Submission

Qualification(s)

Bachelors Degree in pharmacy or Regulatory Affairs or any relevant Life Sciences fields. Master’s Degree preferred for senior-level roles.

RAC certification is a plus.

Experience(s)

10Yrs+ Fluent in English

Technical Skills

• Regulatory Data Management
• Regulatory Publishing
• Document Level Publishing
• Submission Level Publishing
• eCTD Publishing & Submissions
• RIMS
• Document/Content Management Systems
• Product Lifecycle Management
• Registration, Variations & Renewals

Soft Skills

Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills

Competencies

• People & Team Management
• Regulatory Data Management / Publishing
• RIMS & eCTD
• Stakeholder & Client Management
• Strong written and verbal communication
• Planning, prioritization, and time management
• Attention to detail and quality focus
• Problem-solving and ability to work independently

Personal Traits

Positive Attitude, Initiative and Commitment, Detailed Oriented, Team player, Focused and sincere, Perseverance

Roles and Responsibilities

• Lead and manage a team of 2–4 members, including work allocation, mentoring, performance monitoring, and review of deliverables.
• Manage Regulatory Data Management and/or Publishing activities.
• Perform and oversee Document Level and Submission Level Publishing, including eCTD submissions.
• Work with RIMS, Document/Content Management Systems, and other regulatory systems.
• Support product lifecycle activities, including Registrations, Variations, Renewals, and Submissions.
• Ensure timely completion of deliverables while maintaining quality and compliance.
• Coordinate with clients and internal stakeholders for effective project execution.
• Ensure adherence to applicable regulatory guidelines, SOPs, client procedures, and quality standards.