Senior Executive - Regulatory Affairs (Finished Oncology Products)

Smart Moves Consultants; Mumbai; On-site; INR 800,000 - 1,200,000; Full time

Job summary

A recruitment firm is seeking a Senior Executive in Regulatory Affairs for a pharmaceutical manufacturing company in Mumbai, India. The role requires sound knowledge of regulatory and GMP requirements (US FDA, EU GMP, PIC/s) and involves responsibilities like compiling product dossiers, handling regulatory queries, and managing product life cycles. This is a full-time position suitable for candidates with strong documentation and regulatory affairs skills.

Qualifications

• Sound and deep knowledge in current Regulatory / GMP requirements (US FDA, EU GMP, PIC/s).

Responsibilities

• Compile and review product dossiers.
• Conduct gap analysis.
• Handle customer and MOH queries.
• Manage product life cycle.
• Document review and manage administrative documentation.
• Monitor validity of registrations and GMP requirements.

Skills

Regulatory Affairs knowledge

GMP requirements understanding

Strong documentation skills

Job description

Senior Executive - Regulatory Affairs (Finished Oncology Products)

Candidate should be from RA, and actively involved in regulatory affairs function on finished dosage form.

About the Role

Sound and deep knowledge in current Regulatory / GMP requirements (US FDA, EU GMP, PIC/s).

Responsibilities

• Compile and review product dossiers.
• Conduct gap analysis.
• Handle customer and MOH queries.
• Manage product life cycle.
• Handles on Development report, specification, COA, stability protocol and Process validation protocol.
• Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability).
• Re-registration (Renewal) procedures.
• Administrative documents requirements (COPP, Mfg. License and Import License).
• Monitor validity of the Registrations of the FG and Plant GMPs etc.

Required Skills

Sound and deep knowledge in current Regulatory / GMP requirements (US FDA, EU GMP, PIC/s).

Seniority level

Associate

Employment type

Full-time

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing