Experience
- 2 to 6 years
- The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
Education
B. Pharm/M. Pharm from any reputed University.
Requirements
- 2 to 6 years
- The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
Additional Requirements
- Age At most 35 years
- Only Male
At least 2 - 7 years’ experience in Pharmaceuticals.
Practical experience in PD (Dossier and other documents Preparation).
Must have computer knowledge.
Responsibilities & Context
Context:
One Pharma Ltd. embarked on its pioneering journey in November 2015 with a focus on incorporating cutting-edge manufacturing technology and producing globally acclaimed pharmaceutical products for the patients of Bangladesh and beyond. One Pharma Limited is looking for an experienced, reliable, honest & dedicated candidate for the position of Executive/ Senior Executive, Dossier & Other Documents Preparation under Product Development (PD) department for its factory (BSCIC, Bogura).
Job Responsibilities:
To prepare, compile, review, and update pharmaceutical product registration dossiers in accordance with applicable DGDA requirements and relevant International regulatory guidelines.
To prepare and compile CTD/eCTD dossier documents, where applicable, including administrative information, quality documentation, non-clinical data, and clinical data.
To collect, review, and coordinate the required documents from QA, QC, Production, and other relevant departments for dossier preparation.
To prepare and review product-specific documents, including product composition, manufacturing process, specifications, analytical methods, validation reports, stability data and product information.
To ensure the accuracy, consistency, completeness, and regulatory compliance of all dossier documents before submission.
To prepare regulatory applications, justifications, declarations, undertakings, and other supporting documents required for product registration and approval.
To maintain and update dossier records and track regulatory submission status, queries, deficiencies, and responses.
To coordinate with the relevant departments to address regulatory queries and provide additional documents or clarifications as required by DGDA and other applicable regulatory authorities.
To keep up to date with applicable pharmaceutical regulatory guidelines, requirements, and amendments relevant to product registration and dossier submission.
Job Other Benifits
- Provident fund,Tour allowance,Mobile bill,T/A
- Festival Bonus: 2
- Salary Review: Yearly
Competitive Career Growth
Other Financial/Non-financial Benefits