Job highlights

- Lead or support activities related to obtaining and maintaining DSIR certification for the RD Center,including documentation and regulatory coordination
- Bachelors or Masters degree in Pharmaceutical Sciences,Life Sciences,Chemistry,Engineering,Sciences,or a related discipline (depending on domain)

Job Title India RA Manager, RD

Job Profile

Manager- Quality Regulatory- General Quality and Regulatory

Group - Family

Quality- General Quality and Regulatory

Summary

Manages and leads India BRD Drug RA compliance and regulatory execution, including laboratories and external testing partners

Essential Duties and Responsibilities

Regulatory Compliance Leadership

- Ensure full regulatory compliance for RD activities performed at the site.
- Monitor, interpret, and implement evolving regulatory requirements and policy updates impacting RD operations.
- Assess potential business impact arising from regulatory non-compliance. Advise mitigations, and drive implementation of corrective/preventive actions to ensure sustained compliance.

Regulatory Intelligence

- Maintain deep knowledge of India local requirements (e.g., CDSCO, State FDA, CBN, DSIR) and relevant global regulatory expectations (e.g. pharmacopoeial requirements such as EU/US Pharmacopeia expectations where applicable).
- Provide subject matter guidance on import regulations and compliance requirements relevant to Drug Products and Sciences, including RD material movement and sample logistics.
- Demonstrate in-depth expertise in relevant acts/rules governing import, testing, and export-related needs (as applicable to the site scope). Licenses, Registrations, and Permits

- Act as the primary liaison with Central Government authorities (CDSCO)



and State Regulatory Bodies (State FDA) for obtaining, renewing, and maintaining statutory licenses, registrations, and permits.

- Obtain and maintain regulatory licenses/approvals for RD site operations, internal labs, and applicable third-party testing facilities.
- Support and/or lead regulatory compliance for specialized laboratory areas such as formulation labs, container testing labs, sterility assurance, and other RD science capabilities within the site scope.

- Lead or support activities related to obtaining and maintaining DSIR certification for the RD Center, including documentation and regulatory coordination. Agency Interface, Audits, and Inspection Readiness

- Directly interface with regulatory agencies and lead audit/inspection engagements, including driving audit preparation, hosting, and closure activities.
- Lead inspection readiness programs for the site, including documentation readiness, staff preparedness, and response management.

- Manage audit observations, deficiency responses, commitments, and closure documentation within required timelines.

Regulatory Submission Management

- Lead preparation, review, and submission of India registrations, import licenses, technical files, and dossiers, as applicable to RD and site regulatory needs.





- Act as the primary interface for regulatory correspondence with CDSCO and relevant bodies; ensure accurate, timely, and compliant communications.
- Coordinate and manage regulatory portal submissions and tracking (e.g., SUGAM, ONDLS, NSWS and related systems as applicable).

Training and Development

- Develop and disseminate regulatory knowledge to the RD organization through training, coaching, and practical guidance.
- Provide hands-on support and mentoring to team members, ensuring strong regulatory writing, compliance execution, and audit readiness capabilities.

Cross-Functional and Global Stakeholder Collaboration

- Act as an interface with global regulatory teams, RD, manufacturing, and third-party labs; serve as an escalation point for regulatory risks and compliance issues.
- Provide transparent regulatory guidance to project teams and leadership, enabling compliant decision-making and execution.

Qualifications

- Minimum 5+ years of Regulatory Affairs (India) experience with direct hands-on exposure to:

- CDSCO interactions and submissions

- State FDA operations and licensing
- Regulatory audits/inspections and closure management

Education and/or Experience

- Bachelor's or Master's degree in Pharmaceutical Sciences, Life Sciences, Chemistry, Engineering, Sciences, or a related discipline (depending on domain).

- Additional certifications or demonstrated expertise in GLP/GMP, regulatory compliance, or regulatory intelligence are advantageous.

Disclaimer: This job posting has been aggregated from external source.

Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 RA Manager (Bengaluru)
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