Cipla Hiring Team Member – Regional Regulatory Affairs

Are you a skilled regulatory affairs professional seeking a new and exciting challenge? If you have a background in pharmaceuticals and a knack for understanding regulatory requirements, Cipla’s Regional Regulatory Affairs Team Member role could be your next big opportunity. In this role, you’ll play a pivotal part in submitting product documents to regulatory authorities, ensuring approvals and market launches are executed efficiently. Read on to explore this rewarding career opportunity with one of India’s leading pharmaceutical companies.

Vacancies List:

Position Title: Team Member – Regional Regulatory Affairs (79685)

Company Name: Cipla

Salary: Competitive

Company Address: Vikhroli, Maharashtra, India

Detailed Job Description:

Role: Team Member – Regional Regulatory Affairs

Industry Type: Pharmaceuticals

Department: IPD

Employment Type: Permanent

Role Category: Regulatory Affairs

Job Description:

As a Team Member in Cipla’s Regional Regulatory Affairs department, your role will be vital in achieving timely submission of dossier/DMF and deficiency responses to regulatory authorities. This is critical to ensure approvals for product launches occur within stipulated timelines. Your responsibilities will include the following:

I. Timely Dossier Submission:

• Review, collate, and compile documents for the timely submission of dossier/DMF to regulatory authorities.
• Address deficiency responses promptly to expedite approvals for product launches within defined timeframes.

II. Post-Approval Variations:

• Submit post-approval variations for changes aimed at improving productivity, cost-effectiveness, and product quality.
• Review, collate, and compile variation applications to meet delivery deadlines.
• Ensure continuous validity of marketing authorizations by managing Product Marketing Authorization, Renewals, and addressing Sunset clauses.

III. Document Maintenance:

• Maintain and update product dossiers to accommodate changes in Cipla’s internal systems, regulatory guidelines, and other regulatory requirements.

IV. Database Management:

• Update the database associated with product dossier approvals, including registration details.

V. Regulatory Support:

• Provide regulatory support throughout the life cycle of the product to ensure smooth functioning and compliance with regulations.

VI. Dossier Availability:

• Ensure the availability and readiness of dossiers for out-licensing and in-licensing activities.

VII. Regulatory Authorities Interaction:

• Collaborate with regulatory authorities, including EU, NZ, and TGA, to track submission activity and approval statuses for completed submissions.

Education Qualification:

• B.Pharmacy, M.Pharm, BSc, or MSc

Relevant Work Experience:

• Minimum of 5 years of experience in regulatory activities within the pharmaceutical industry, preferably having worked within the same region or authority.

Competencies/Skills:

• Communication Skills (clarity of thought, comprehension)
• 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, Outspoken, Maturity Level, etc.)

Job Location: Vikhroli, Maharashtra, India