Manager Regulatory Affairs / Quality Assurance Manager (Biologics)

Job Title: Manager - Regulatory Affairs / Quality Assurance

Company:

Location:

Experience:

Vaccine, Injectable, and Sterile Industry

Educational Qualification:

• Bachelors or Masters in Pharmacy
• M.Sc in Biotechnology, Microbiology, or a related field
• Additional qualifications in life sciences or pharmaceutical sciences are a plus

Job Overview:

Manager QA / Regulatory Affairs

Key Responsibilities:

1. Regulatory Strategy & Compliance:

• Develop and execute

  regulatory strategies

  to ensure compliance with global standards for

  vaccine

  ,

  injectable

  , and

  sterile products

  .
• Maintain a strong understanding of global regulatory requirements, including

  FDA

  ,

  EMA

  ,

  WHO

  , and

  local regulations

  like

  CDSCO

  to guide product approvals and market entry.
• Ensure alignment of product development and manufacturing processes with

  Good Manufacturing Practices (GMP)

  ,

  Good Laboratory Practices (GLP)

  , and other relevant

  GxP

  standards.

2.Audit & Inspection Management:

• Coordinate and manage

  regulatory audits

  (e.g.,

  CDSCO

  ,

  EU GMP

  ) for

  vaccine

  ,

  injectable

  , and

  sterile

  products, ensuring full compliance and readiness across all departments.
• Lead the preparation for

  regulatory inspections

  related to

  CDSCO

  and

  EU GMP

  , working closely with relevant teams to ensure effective corrective actions and continuous compliance.
• Manage responses to audit findings and ensure the implementation of corrective actions in line with industry standards.

3.Quality Management System (QMS):

• Oversee the implementation and management of the

  Quality Management System (QMS)

  to ensure product quality and regulatory compliance.
• Lead the development and review of

  Standard Operating Procedures (SOPs)

  , ensuring that they align with current regulatory requirements for vaccine and sterile product manufacturing.
• Monitor and ensure compliance with the

  QMS

  framework across all departments to maintain consistent product quality.

4. Regulatory Submissions & Documentation:

• Oversee the preparation, compilation, and submission of

  regulatory dossiers

  and

  eCTD documents

  to regulatory bodies (e.g.,

  FDA

  ,

  EMA

  ,

  CDSCO

  ).
• Ensure that all required documentation and records are properly maintained and comply with regulatory standards, ensuring smooth regulatory approvals for

  vaccine

  ,

  injectable

  , and

  sterile products

  .

5.Risk Assessment & Mitigation:

• Conduct

  regulatory risk assessments

  to identify potential issues related to product development, manufacturing, and compliance.
• Develop and implement risk mitigation strategies to ensure uninterrupted production and compliance with regulatory standards.

6.Cross-Functional Collaboration:

• Collaborate with internal teams such as R&D, Production, and Quality Control to ensure regulatory compliance throughout the product lifecycle, from development to post-market surveillance.
• Provide regulatory guidance and training to cross-functional teams, ensuring awareness of applicable

  QA

  practices and

  regulatory requirements

  .

7.Corrective and Preventive Actions (CAPA):

• Lead the implementation of

  Corrective and Preventive Actions (CAPA)

  to address audit findings, non-conformities, and deviations, ensuring continuous improvement in compliance and quality practices.

Key Skills and Competencies:

• Expert Knowledge of Regulatory Guidelines

• Regulatory Submissions & Documentation Expertise

• Audit & Inspection Management

• Quality Management System (QMS) Oversight

• Risk Management & Mitigation

• Strong Leadership & Project Management

• Corrective & Preventive Action (CAPA) Implementation

• Excellent Communication Skills

About GreenSignal Bio Pharma Pvt Ltd

vaccine

For more information, please visit: www.gsbpl.com

How to Apply:

Interested candidates can apply via email at: hr@gsbpl.com

For inquiries, please contact us at: +91 8778926365

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