Tiefenbacher Laboratories is thrilled to announce an exciting career opportunity in the Regulatory Affairs department. We are looking for experienced professionals to join our team as Executive, Senior Executive, or Assistant Manager in the Regulatory Affairs-RIMS & Bioanalytical- QA/QC. If you are passionate about regulatory compliance and eager to work with a company that values a healthy work-life balance, this is the perfect opportunity for you.
Open Position
Job Title: Executive / Sr. Executive / Asst. Manager
Department: Regulatory Affairs-RIMS
Location: Hyderabad
Required Qualifications and Experience
| Position | Experience | Qualifications |
|---|---|---|
| Executive | 4-8 years | B.Pharmacy, M.Pharmacy, MSc, or any relevant pharma degree |
| Sr. Executive | 4-8 years | B.Pharmacy, M.Pharmacy, MSc, or any relevant pharma degree |
| Asst. Manager | 4-8 years | B.Pharmacy, M.Pharmacy, MSc, or any relevant pharma degree |
Key Responsibilities
Regulatory Information Management System (RIMS)
- Primary Contact: Serve as the primary point of contact for Regulatory Affairs concerning RIMS (Regulatory Information Management System).
- Supervision: Provide direct oversight of RIM activities, coordinating with vendors, stakeholders, and colleagues responsible for interfacing systems.
- Industry User Administration: Act as the Industry User Administrator in the EMA Account Management Portal for User Account Management, particularly for PLM (Product Lifecycle Management) and upcoming projects like ePI (Electronic Product Information).
Data Management and Compliance
- EVMPD and IDMP Support: Manage and support EVMPD (Extended EudraVigilance Medicinal Product Dictionary) data while implementing IDMP (Identification of Medicinal Products) within the company.
- Stakeholder Engagement: Engage with regulatory authorities, industry working groups, and technology vendors to ensure compliance and active participation in relevant forums and EMA webinars.
- Compliance Monitoring: Regularly monitor and assess adherence to IDMP standards, ensuring ongoing compliance.
Training and Support
- Electronic Regulatory Affairs: Support the department in all electronic issues related to regulatory affairs and pharmacovigilance.
- RIMS User Training: Conduct workshops, create training materials, and lead information management system training sessions to educate RIMS users.
Why Join Tiefenbacher Laboratories?
Tiefenbacher Laboratories is a well-respected name in the pharmaceutical industry, known for its commitment to quality and innovation. We offer a dynamic and supportive work environment where employees are encouraged to grow and develop their skills. Joining our Regulatory Affairs team means being part of a company that values both professional excellence and personal well-being.
Location
Our offices are located in Hyderabad, a city known for its rich history and vibrant culture. Hyderabad is a major hub for the pharmaceutical industry in India, offering ample opportunities for professional growth and networking.
How to Apply
If you meet the qualifications and are interested in joining our team, please send your resume to:
- G. Lakshmi: g.lakshmi@tiefenbacher.com
- K. Surendra: k.surendra@tiefenbacher.com
We look forward to hearing from you and exploring the possibility of you joining the Tiefenbacher Laboratories family.
For more information about Regulatory Affairs, you can refer to the Wikipedia article on Regulatory Affairs.
Conclusion
This opportunity at Tiefenbacher Laboratories is more than just a job—it’s a chance to build a rewarding career in a company that cares about its employees. With the ever-evolving landscape of regulatory compliance, your expertise in Regulatory Affairs will be invaluable. Join us and contribute to our mission of maintaining the highest standards in pharmaceutical products and services.
