Location : Chennai, Mumbai, or Pune

Exp : 15-20 Years

PRIMARY RESPONSIBILITIES :

The Life Sciences (Associate) Regulatory Compliance Officer will coordinate and support activities to achieve, monitor, and maintain operational regulatory compliance in the following, but not limited to, areas:

- Develops, implements and manages regulatory compliance program as required for some or all of Life Sciences CRO and CRO component services (BPO, BPaaS, PaaS, SaaS delivery models); Life Sciences Products and Platforms lines of business and other tools used in support of regulated activities.

- Provides thorough regulatory compliance oversight, internal advisory/consulting and monitoring/reporting activities to ensure compliance with all applicable global regulations.

EDUCATION/EXPERIENCE/MINIMUM REQUIREMENTS :

Education :

- Bachelor's Degree in political science, law, business, scientific, computer science or related field is required; Graduate Degree in political science, law (J.D.), business or scientific field is highly desirable and preferred.

Certification/License :

- One of the following certifications (e.g., SQA, RAC, SCDM, CHC, CCEP, or CIPP/US) is highly desirable.

Experience :

- Minimum of at least fifteen (15-20) years of experience in regulatory compliance and/or government regulatory affairs roles as well as experience in a pharmaceutical-related or CRO environment is required.

Qualifications, Knowledge, Skills & Abilities :

- Deep, global regulatory and procedural knowledge of some or all of the following: cGMP, GCP, GLP, ICH, 21 CFR Part 11, and Annex 11, GDPR, HIPAA, IEEE GAMP

- Ability to collaborate with Corporate Compliance, Regulatory Legal, Privacy, Information Security, Commercial Legal, and Corporate Legal, when appropriate (e.g., adverse situations needing interpretation or potential issue escalation).

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.