Cipla is a leading global pharmaceutical company based in India. Founded in 1935 by Dr. Khwaja Abdul Hamied, Cipla has grown to become one of the largest pharmaceutical companies in India and has a significant presence in over 80 countries worldwide.
Cipla is known for its focus on providing affordable healthcare solutions, particularly in the areas of respiratory, cardiovascular, anti-infective, and oncology medications. The company has a strong emphasis on research and development, consistently innovating to bring new drugs to market.
In recent years, Cipla has expanded its operations through strategic acquisitions and partnerships, further solidifying its position in the global pharmaceutical industry. They are also actively involved in corporate social responsibility initiatives, particularly in the areas of healthcare access and education.
Job Posting: Team Member – Regional Regulatory Affairs (85029)
Job Description
Job Purpose
The primary goal is to submit product documentation to regulatory authorities in alignment with country-specific regulatory requirements, ensuring timely approvals and market launches. Additionally, this role involves managing post-approval changes, maintaining, and updating documents throughout the product’s life cycle.
Accountabilities
I. Timely Submission
- Ensure the prompt submission of dossiers/DMFs and responses to deficiencies by meticulously reviewing, collating, and compiling necessary documents. This ensures product approvals and timely market launches.
II. Post-Approval Variations
- Submit post-approval variations to enhance productivity, cost-effectiveness, and product quality by carefully reviewing, collating, and compiling variation applications. Maintain Product Marketing Authorizations, Renewals, and Sunset clauses to ensure ongoing validity.
III. Dossier Maintenance
- Maintain and update product dossiers to reflect changes in Cipla’s internal systems, regulatory guidelines, and other regulatory requirements.
IV. Database Updates
- Regularly update the product dossier approval database (PRC/SAP-RA/table) by including registration details.
V. Regulatory Support
- Provide continuous regulatory support throughout the product’s life cycle to ensure smooth operations.
VI. Dossier Availability
- Ensure the availability and suitability of dossiers for out-licensing and in-licensing opportunities.
VII. Regulatory Communication
- Liaise with regulatory authorities (EU, NZ, and TGA) to track submission activities and approval statuses.
Candidate Profile
Qualifications:
- B.Pharmacy, M. Pharm, B.Sc, or M.Sc
Experience:
- Minimum of 5 years in regulatory activities within the pharmaceutical industry, preferably with experience in the same region/authority.
Core Competencies:
- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
Skills:
- Strong domain knowledge
- Effective people management
Additional Information
- Experience: 5 years
- Qualifications: M.Pharm, B.Pharm, M.Sc, B.Sc
- Location: Maharashtra, Vikhroli
- Industry Type: Pharma/Healthcare/Clinical Research
- Functional Area: Regional Regulatory Affairs
- End Date: 30th June 2024
This role offers a challenging and rewarding opportunity for individuals passionate about regulatory affairs and eager to contribute to Cipla’s mission of providing accessible and affordable healthcare solutions.
