Regulatory Compliance Officer - Life Science

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).