Tiefenbacher Labs Hiring Sr. Executive – Regulatory Affairs
- Sr. Executive – Regulatory Affairs (M.Pharm) | Tiefenbacher
- Company Overview
- Job Role & Responsibilities
- Eligibility / Qualifications
- Location & Salary
- Application Process
- Why Join Tiefenbacher Laboratories?
- FAQs
- Job Summary Table
Sr. Executive – Regulatory Affairs (M.Pharm) | Tiefenbacher
Tiefenbacher Labs hiring Sr. Executive/Executive Regulatory Affairs for ROW markets. M.Pharm, 4–6 yrs exp. Hyderabad.
Tiefenbacher Laboratories is seeking an experienced Senior Executive / Executive – Regulatory Affairs (ROW Markets) to join its regulatory team in Hyderabad. This role is ideal for M.Pharm professionals with 4–6 years of hands-on experience managing CTD/ACTD dossier submissions and product lifecycle activities for Rest‑of‑World (ROW) regions such as GCC, MENA, ASEAN, and CIS.
Company Overview
Tiefenbacher Laboratories is a forward‑looking pharmaceutical organization operating from Hyderabad, focused on global market registrations and compliance support for innovative and generic products. The company partners with business development teams and international clients to deliver regulatory strategies that meet global standards and enable timely market access across multiple regions.
Tiefenbacher emphasizes scientific rigor, regulatory compliance, and transparent client collaboration — making it a trusted partner for global product registrations and lifecycle management.
Job Role & Responsibilities
Designation: Senior Executive / Executive – Regulatory Affairs (ROW Market)
Qualification: M.Pharm
Experience: 4–6 Years
Location: Hyderabad (Gaddapotharam, Kazipally Industrial Area)
Key Responsibilities:
- Independently prepare, compile and submit CTD / ACTD dossiers (Modules 1–5) tailored to country‑specific requirements for GCC, MENA, ASEAN, CIS and other ROW markets.
- Lead product lifecycle activities including registration maintenance, variation submissions, renewals, and labeling updates to ensure continuous market compliance.
- Interpret and implement regional regulatory guidelines; keep abreast of updates and ensure timely incorporation into dossiers and submissions.
- Liaise closely with Business Development, QA, QC, Manufacturing and external clients/CROs to align on regulatory strategy and submission timelines.
- Respond to regulatory queries, coordinate technical clarifications, and manage submission trackers and timelines.
- Review and approve regulatory documents, SmPCs, PILs, and packaging inserts per local regulations and company standards.
- Support regulatory audits and inspections when required and maintain organized regulatory files and documentation.
Eligibility / Qualifications
Educational Requirements:
- Master’s degree in Pharmacy (M.Pharm) — Regulatory Affairs, Pharmaceutics, Pharmaceutical Analysis, or related specialization preferred.
Experience Requirements:
- 4–6 years of demonstrated experience in regulatory affairs, preferably handling ROW market submissions and CTD/ACTD dossier compilation.
Desired Skills:
- Strong knowledge of CTD/ACTD formats, country-specific regulatory requirements (GCC, MENA, ASEAN, CIS), and global regulatory frameworks (ICH, WHO).
- Excellent technical writing, dossier compilation and review skills.
- Proficiency in lifecycle management (variations, renewals, labeling changes).
- Good interpersonal, client-facing and project coordination skills.
- Attention to detail, time management and ability to work independently.
Location & Salary
Work Location: Survey No. 42, Gaddapotharam, Kazipally Industrial Area, Sanga Reddy Dist., Hyderabad – 502319, Telangana.
Company: Tiefenbacher Laboratories
Salary: Competitive and commensurate with experience (industry standard).
Employment Type: Full-Time, Permanent
Application Process
Interested candidates with the relevant qualifications and experience may apply by sending their updated CV to the HR email below. Please mention “Application – Regulatory Affairs (ROW)” in the subject line for quicker processing.
Email: k.surendra@tiefenbacher.com
Why Join Tiefenbacher Laboratories?
- Opportunity to work on international regulatory submissions and gain exposure across multiple ROW markets.
- Collaborative role interfacing with business development and global clients, enhancing professional visibility.
- Work in a growing regulatory team that values accuracy, science-driven decisions, and timely market access.
- Competitive compensation, professional development, and a supportive work culture.
FAQs
1. What is the primary role of this position?
To manage end‑to‑end CTD/ACTD submissions and product lifecycle activities for ROW markets independently.
2. Is M.Pharm mandatory?
Yes, a Master’s in Pharmacy (M.Pharm) is required for this role.
3. Which regions will the candidate handle?
Primarily GCC, MENA, ASEAN, and CIS regions and other ROW markets as assigned.
4. How do I apply?
Send your CV to k.surendra@tiefenbacher.com with the subject “Application – Regulatory Affairs (ROW)”.
5. Is prior ROW experience mandatory?
Prior experience with ROW submissions is strongly preferred and will be advantageous.
Job Summary Table
| Category | Details |
|---|---|
| Company | Tiefenbacher Laboratories |
| Vacancies | Senior Executive / Executive – Regulatory Affairs (ROW) |
| Required Education | M.Pharm |
| Experience | 4–6 Years |
| Location | Gaddapotharam, Kazipally Industrial Area, Hyderabad – 502319 |
| k.surendra@tiefenbacher.com | |
| Salary | Competitive; industry standard |
To apply for this job email your details to k.surendra@tiefenbacher.com
