Assistant Manager – Regulatory Management Jobs at Getz Pharma in Karāchi, Sindh

Getz Pharma is currently accepting applications for the position of Assistant Manager - Regulatory Management in the Sindh area. The job type available for this position is Full-time.

We are looking for candidates who possess proficient Other skills and have a minimum of Associate in the respective field. In addition to technical expertise, we highly value traits such as honesty, discipline, and a strong sense of responsibility in our prospective employees.

The company offers a competitive estimated salary of approximately Rs 25,000 - Rs 80,000 (per Month). However, it is important to note that the final salary offer may vary and is subject to the discretion of the company.

Getz Pharma operates within the Pharmaceutical Manufacturing industry. If you are interested in applying for this position and joining our esteemed organization, we encourage you to submit your application promptly.

Job Information

Job Description

Responsible for preparation of product registration dossiers and other related applications (Renewals, Licenses and Variations) for onward submission to Drug Regulatory Authority overseas as per CTD/ACTD format or national guidelines.

Job Responsibilities

• Coordinate with QC / QA / R&D for any inquiry of test methods and reference.
• Prepare monthly reports, meeting minutes and progress trend analysis.
• Assist in preparation of monthly plan for dossier preparation and other related activities.
• Responsible to collate, compile and preparation of product registration dossiers and other related applications required for submission to Drug Regulatory Authority Overseas.
• Preparation of variation applications according to the variation requirements of respective Drug Regulatory Authority.

Required Knowledge and Experience

• Holds a professional degree of Pharmacy (Pharm D), with strong communication skills and command in computer (MS Office, Adobe Acrobat, Power Point) skills.
• Should have in-depth business understanding of WHO and ICH guidelines, along with understanding of the role of Regulatory affairs department in pharmaceutical industry.
• Should have good understanding of guidelines for filing of international dossiers.
• Knowledge of pharmaceutical regulations, including drug development, clinical trials, and post-market surveillance.
• 4-6 years of relevant work experience in any reputed pharmaceutical company.

Benefit

• Overtime bonus
• Gaining experience
• Comfortable work environment

Application Requirements

• Relevant formal education
• Work experience in the related industry is a plus
• Ability to adapt and learn quickly

Company address