Cipla Hiring Regional Regulatory Affairs Team Member | Mumbai

Cipla Hiring Regional Regulatory Affairs Team Member | Apply for Regulatory Affairs Role in Mumbai

Cipla, one of India’s leading pharmaceutical companies, is hiring a Regional Regulatory Affairs Team Member in Mumbai. This permanent position offers you the opportunity to be part of a dynamic team, contributing to the timely approval and launch of pharmaceutical products across diverse global markets.

If you have a background in pharmacy or life sciences, along with expertise in regulatory affairs, this role could be the perfect fit for you.

Job Title: Regional Regulatory Affairs Team Member

• Location: Mumbai, Maharashtra, India
• Employment Type: Permanent
• Department: IPD (Innovation & Product Development)
• Posting Date: 22nd September 2024
• Job ID: 87093

Key Responsibilities

As a Regional Regulatory Affairs Team Member at Cipla, you will be responsible for:

1. Dossier Submission: Reviewing, collating, and compiling documents for timely submission of dossiers and deficiency responses to regulatory authorities. Your work ensures product approval
2. Achieve timely submission of dossier/DMF and deficiency responses to regulatory authority by reviewing, collating, and compiling documents in order to ensure approvals for launch in stipulated time
3. Submit post approval variations for changes that improves productivity, cost-effectiveness, quality of the product by reviewing, collating, compiling the variation application to meet the delivery within timelines and maintain Product Marketing Authorization, Renewals/Sunset clause to ensure continuous validity of marketing authorisations.
4. Maintain, and update product dossier as required to meet changes in Ciplas internal systems, changes in regulatory guidelines, and to meet the need of regulatory requirements
5. Update the database (PRC/SAP-RA/ table) associated with product dossier approvals by including registration details in database.
6. Provide Regulatory support throughout the life cycle of the product for smooth functioning
7. Provide the informatuitability and availability of dossier for out-licensing and in-licensing
8. Check with regulatory authorities (EU, NZ & TGA) for submission activity and approval status for submission done

Qualifications and Skills

To qualify for this role, candidates must meet the following criteria:

• Education:
  • B.Pharmacy, M.Pharm, BSc, or MSc in a relevant field.
• Experience:
  • At least 5 years of experience in regulatory affairs, particularly in the pharmaceutical industry. Experience working with the same region/authorities will be a plus.
• Key Competencies:
  • Strong domain knowledge of regulatory requirements.
  • Excellent collaboration and communication skills.
  • Ability to innovate, take accountability, and act with agility in a fast-paced environment.
  • Strong people management and leadership abilities.

Location Information

This position is based in Mumbai,

How to Apply

Apply now for the Regional Regulatory Affairs Team Member position at Cipla by visiting the Cipla Careers Portal.