Job Description

Division

IPD

Department

IPD

Employment Type

Permanent

Job Purpose

Execute the regulatory assurance and training processes by maintaining RA documentation systems, tracking regulatory commitments and annual report submissions to achieve regulatory assurance for Cipla

Accountabilities

• Compile required technical documents to ensure timely submission of dossiers.
• Coordinate with stakeholders for data collation and tracking progress of the projects
• Ensure partnering, collaboration and coordination with other functions such as Formulation & Analytical Development, Medical, Marketing, Strategy, Legal, Corporate Affairs, Sourcing, Packaging, CQA, Manufacturing sites, etc. during various stages of product registration and life cycle management and provide RA inputs.
• Search Product information and other product related references from available sources to provide high level regulatory information to aid decision making during portfolio product evaluation, various stages of product development and technical/ GMP audits of manufacturing facilities.
• Maintain files/trackers to reflect up to date status of product development, dossier compilation and query responses on regular basis.
• Prepare RA Strategy in consultation with Head of the department for new development or leverage products planned for India market.
• Plan and actively contribute to Internal and External engagement activities.
• Reconciliation of GPL Database (Global Product List)
• Work on software such as Trackwise, Cipdox, etc.
• Participate in Learning Management System and Training activities

Education Qualification

B.Pharm /M.Pharm or Science Graduate

Relevant Work Experience

3 to 5 years in Regulatory Affairs Department of Pharmaceutical company is desirable. Experience of QA / QC can also be considered.

Competencies/Skills

Communication Skills (clarity of thought, comprehension)

Likely potential for growth

Job / Product / Technical Knowledge / Pharma domain knowledge

Presentation & Interpersonal skills (If applicable)

Managerial or People Management skills

Safety awareness (If applicable)

Relevance of Previous Experience

Comprehension, Analytical & Problem solving abilities

Productivity & Result Orientation (If applicable)

Attitude

Qualification fitment

Sales drive (If applicable)

Personality traits (Individualistic / Team player, Out spoken, Maturity level etc.)

Job Location

Vikhroli

Shift Hours

Cipla