Manager, RA_QA

Summary:

This section focuses on the main purpose of the job in one to four sentences.

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 R&D activities performed at the site.

-Monitor, interpret, and implement evolving regulatory requirements and policy updates impacting R&D 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 R&D 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 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.

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 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).

Training and Development:

-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.

Cross-Functional and Global Stakeholder Collaboration

-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.

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

-Pharma R&D experience is strongly preferred, with capability to support lab-based compliance environments (formulation/analytical/testing/sterility assurance scope as applicable).

-Excellent regulatory writing and documentation skills with strong attention to detail and compliance mindset.

-Strong coordination skills and ability to manage complex stakeholders across global and local teams.

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.