manufacturing standards, and providing mentorship to junior staff as the organization
scales its operations.
Key Responsibilities
● Audit Readiness: Lead the preparation and management of documentation for
imminent audits, including USFDA, CDSCO, ISO, and HIPAA.
● Compliance Oversight: Ensure all processes align with Good Manufacturing
Practices (GMP) and other pharmaceutical regulatory requirements.
● Certification Management: Oversee the application, renewal, and maintenance
of all necessary organizational certifications.
● Team Mentorship: Act as a subject matter expert and provide technical guidance
to junior team members/freshers within the regulatory department.
● Strategy & Scaling: Collaborate with the Head of Supply Chain to develop
regulatory strategies that support the rapid scaling of the facility.
Required Qualifications
● Experience: Minimum of 3 years of core experience in Regulatory Affairs.
● Industry: Strictly Pharmaceutical background (Candidates from
Hospital/Healthcare backgrounds will not be considered for this specific role).
● Technical Expertise: * Proven exposure to USFDA and CDSCO guidelines.
○ In-depth knowledge of GMP (Good Manufacturing Practices).○ Hands-on experience with ISO and HIPAA compliance standards.
● Education: Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm) or
a related life sciences field.
Compensation & Benefits
● Salary: ₹7.2 LPA – ₹8.4 LPA (₹60,000 – ₹70,000 per month), commensurate with
experience.
● Location: [Harohalli Industrial Area, Ramanagara, Karnataka.
● Employment Type: Full-Time, Permanent.
Candidate Attributes
● Ability to work under tight deadlines (specifically for audit windows).
● Strong analytical skills with a high degree of accuracy in documentation.
● Willingness to work in a high-intensity environment during scaling phases.

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