Location: Navi Mumbai
Industry: Pharma/Healthcare/Clinical Research
Functional Area: Regulatory Affairs
Experience Required: 2 to 5 years
Qualifications: M.Pharm, B.Pharm, MSc, B.Sc
Application Deadline: 10th November 2024
About Teva: Teva is dedicated to making good health more affordable and accessible, helping millions enjoy healthier lives across nearly 60 countries. As a leading manufacturer of generic medicines and a proud producer of products on the World Health Organization’s Essential Medicines List, we are always seeking passionate individuals to join our mission.
Position: Regulatory Affairs Associate I
Job Description: As a Regulatory Affairs Associate, you will act as a project manager responsible for the lifecycle management of Medis dossiers for Teva’s 3rd party client business. Key responsibilities include:
- Ensuring smooth information flow and provision of supportive documents to clients.
- Liaising with Teva’s 3rd party client business, supply chain, and relevant functions.
- Managing lifecycle processes for specific products in Europe and international markets.
- Keeping regulatory modules up to date in line with agreed procedures.
- Preparing and submitting variations to authorities or clients.
- Following up on submission timelines and approvals.
- Compiling responses to deficiency questions from authorities or clients.
- Communicating outcomes of variations and maintaining updated databases.
- Providing regular status updates to management.
- Collaborating on goal setting with supervisors.
- Engaging in professional communications with internal and external stakeholders.
- Participating in specialized projects as assigned by RA managers.
Candidate Profile:
- Education:
- M.Pharm/M.Sc with 2 to 3 years of RA experience
- B.Pharm/B.Sc with 3 to 5 years of RA experience
- Experience: Minimum 1 year of relevant experience in the EU.
- Skills:
- Excellent organizational, communication, and presentation skills.
- Proficient in written and verbal English.
- Strong strategic thinking and adaptability to change.
- Team player with good computer skills.
- Proactive and able to work independently.
How to Apply: If you’re interested in making a difference in the healthcare industry, please submit your application by 10th November 2024. Join us in our mission to improve global health!