 Company: Cipla
Location: Vikhroli, Maharashtra
Industry: Pharma/Healthcare/Clinical Research
Experience Required: Minimum 5 years
Qualification: B.Pharm, M.Pharm, B.Sc, M.Sc
Application Deadline: 30th October 2024
About Cipla
Cipla is a global healthcare company dedicated to the mission of “Caring For Life.” With a presence in over 80 countries and a portfolio of more than 1,500 products across various therapeutic categories, we are committed to making healthcare affordable and accessible worldwide.
Job Description
As a Regional RA Team Member, you will play a crucial role in ensuring timely submissions of product documents to regulatory authorities, facilitating approvals, and managing the lifecycle of products.
Key Responsibilities
- Dossier Submission: Achieve timely submissions of dossiers and deficiency responses to regulatory authorities for product approvals.
- Post-Approval Variations: Submit applications for post-approval changes to enhance product quality and cost-effectiveness, ensuring continuous validity of marketing authorizations.
- Documentation Maintenance: Maintain and update product dossiers in accordance with changes in internal systems and regulatory guidelines.
- Database Management: Update the relevant databases with registration details and approval statuses.
- Regulatory Support: Provide ongoing regulatory support throughout the product lifecycle for seamless operations.
- Licensing Support: Ensure the availability of dossiers for out-licensing and in-licensing opportunities.
- Communication with Authorities: Coordinate with regulatory authorities (EU, NZ & TGA) regarding submission activities and approval statuses.
Candidate Profile
- Educational Background: B.Pharm, M.Pharm, B.Sc, M.Sc
- Experience: Minimum of 5 years in regulatory activities within the pharma industry, preferably with experience relevant to the region/authority.
- Skills:
- Strong domain knowledge in regulatory affairs
- Excellent collaboration and people management skills
- Ability to innovate and excel in a dynamic environment
- Accountability and agility in performance
- Leadership with empathy
Why Join Cipla?
At Cipla, we value our employees and are committed to their growth and development. Join us in our mission to improve global healthcare and make a meaningful impact in the lives of patients.
Interested candidates are encouraged to apply by submitting their resume and cover letter by 30th October 2024.
