RA Manager

-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 R&D 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 R&D science capabilities within the site scope.

-Lead or support activities related to obtaining and maintaining DSIR certification for the R&D Center, including documentation and regulatory coordination.

-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.

-Lead preparation, review, and submission of India registrations, import licenses, technical files, and dossiers, as applicable to R&D 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).

-Develop and disseminate regulatory knowledge to the R&D 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.

-Act as an interface with global regulatory teams, R&D, manufacturing, and third-party labs; serve as an escalation point for regulatory risks and compliance issues.

-Provide clear regulatory guidance to project teams and leadership, enabling compliant decision-making and execution.

-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.

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