Regulatory Affairs-Team Leader

Brooks Steriscience; Karjan; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Brooks Steriscience in India, Gujarat is seeking a Team Leader (Regulated Markets) with 7 to 10 years of experience in Regulatory Affairs. The role focuses on DMF/CEP submissions, deficiency management, post-approval changes, and lifecycle management in global markets.

Collaboration with R&D, QA, QC, and Manufacturing is essential. The candidate should have combined API and FDF exposure, and will drive regulatory strategy and documentation across CTD/eCTD formats while ensuring compliance and

Qualifications

• Regulatory submissions including DMF/CEP/ASMF globally.
• CTD/eCTD compliant submissions.
• Coordinate with R&D, QA, QC, and Manufacturing for DMF planning and on-time filing.
• Address deficiencies within timelines and prevent repeats.

Responsibilities

• Regulatory submissions: compile and file DMF/CEP/ASMF globally.
• Ensure CTD/eCTD compliant submissions.
• Coordinate with R&D, QA, QC, Manufacturing for DMF planning and filing.
• Address deficiencies within timelines and prevent repeats.
• Post-Approval Variations and Lifecycle: file post-approval changes and amendments.
• Track submission timelines and approvals.
• Regulatory compliance and strategy: align with regional guidelines and evolving rules.
• Support lifecycle management strategy.
• Documentation and Regulatory Operations: maintain trackers, databases, archives, and perform reviews.
• Handle deficiency responses and queries from authorities.

Skills

Regulatory Affairs

Global regulatory experience

DMF/CEP submissions

Deficiency management

Lifecycle management

Cross-functional coordination

Tools

CTD/eCTD

Job description

Team Leader (Regulated Markets 7 to 10 Years of experience)

• Regulatory Affairs with strong experience in Global markets (US, EU & ROW) demonstrating solid understanding of current regulations and guidance. The role involves handling DMF/CEP submissions, deficiency management, post-approval changes and lifecycle management activities in compliance with global regulatory requirements.

• Candidates should be having a combine experience of API & FDF.

Key Responsibilities:

1. Regulatory Submissions (Initial Filings & Deficiency management):

• Preparation, compilation, and submission of DMF/CEP/ASMF per global requirements
• Providing submissions are compliant with CTD/eCTD formats
• Coordinate with cross-functional teams (R&D, QA, QC, Manufacturing) for DMF planning and on time filing
• Manage and respond to deficiencies within the stipulated timeline and ensure there are no repeat deficiencies

2. Post-Approval Variations & Lifecycle Management:

• Assess and provide filing strategies for post approval changes, and ensure timely filings
• Manage amendments & annual report filings
• Track submission timelines and approvals

3. Regulatory Compliance & Strategy:

• Ensure compliance with regional regulatory guidelines and requirements
• Interpret evolving regulatory requirements and implement changes
• Support regulatory strategy for lifecycle management

4. Documentation & Regulatory Operations:

• Maintain regulatory trackers, databases, and archives
• Perform technical review for completeness and compliance
• Handle deficiency responses and queries from regulatory authorities