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 robust 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
Robust 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.

📌 Team Lead Publishing & Submission Bengaluru
🏢 Celegence Systems
📍 Bengaluru