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 solid 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.

📌 Team Lead-Publishing & Submission (Bengaluru)
🏢 Celegence Systems
📍 Bengaluru