Team Lead-Publishing & Submission

Celegence Systems; Bengaluru; Hybrid; INR 2,500,000 - 3,800,000; Full time

Job summary

Celegence Systems in Bengaluru seeks a seasoned Regulatory Affairs Manager to lead a small team and oversee data management, publishing, and submissions across lifecycle activities.

The ideal candidate has 10+ years in life sciences, a Bachelor’s degree, RAC a plus, and strong English communication, with the ability to coordinate with clients and regulators to ensure timely, compliant deliverables.

Qualifications

• Bachelors degree in pharmacy or regulatory affairs or life sciences; master's preferred for senior roles.
• RAC certification is a plus.

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.

Skills

Fluent English

Verbal communication

Written communication

Strategic thinking

Influence / negotiation

Team leadership

Education

Bachelor's in Pharmacy/Reg Affairs/Life Sciences

Master's degree preferred

Tools

Regulatory Data Mgmt

Regulatory Publishing

eCTD Publishing

RIMS

Document Management

Product Lifecycle Mgmt

Regulatory Submissions

Job description

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.