Manager, RA_QA

Job Description
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 guida...