Job Description
Title: Executive/Sr. Executive, Global Regulatory Affairs
Company Name: A Listed Reputed Pharmaceuticals Company
Vacancy: 01
Age: at most 32 years
Location: Narayanganj (Rupganj)
Minimum Salary: Negotiable
Published: 4 Jul 2024
Education:
∎ M.Pharm or M.Sc. in Biochemistry/Chemistry
∎ M.Pharm or M.Sc. in Biochemistry/Chemistry
Requirements:
Additional Requirements:
∎ Age at most 32 years
∎ (2-3) years of related (Global Regulatory) experience is preferable
∎ Well conversant in MS Office.
∎ Good interpersonal and communication skills.
∎ Strong personal & professional ethical values are essential for the position.
∎ Capable to work in a team and in shifting environment.
∎ (2-3) years of related (Global Regulatory) experience is preferable
∎ Well conversant in MS Office.
∎ Good interpersonal and communication skills.
∎ Strong personal & professional ethical values are essential for the position.
∎ Capable to work in a team and in shifting environment.
Responsibilities & Context:
∎ Responsible for preparing registration dossiers (e.g., CTD, ACTD, etc.) in accordance with the specific requirements of various countries.
∎ Possess expertise in various validation activities, including process validation and analytical method validation (e.g., Assay, Dissolution, Impurity, Residual Solvent, etc.), to check document from QC and PD.
∎ Manage and address queries and deficiencies (e.g. NODs) received from foreign drug authorities.
∎ Conduct comprehensive data checks, covering stability, specifications, standard test methods, standard operating procedures, Certificates of Analysis, Batch Manufacturing Records, Formulations and Batch Packaging Records, while performing gap analysis through document reviews from QC, QA, production, and engineering departments.
∎ Demonstrate a deep understanding of various regulatory guidelines such as ICH, WHO TRS, and PICS, among others
∎ Responsible for preparing registration dossiers (e.g., CTD, ACTD, etc.) in accordance with the specific requirements of various countries.
∎ Possess expertise in various validation activities, including process validation and analytical method validation (e.g., Assay, Dissolution, Impurity, Residual Solvent, etc.), to check document from QC and PD.
∎ Manage and address queries and deficiencies (e.g. NODs) received from foreign drug authorities.
∎ Conduct comprehensive data checks, covering stability, specifications, standard test methods, standard operating procedures, Certificates of Analysis, Batch Manufacturing Records, Formulations and Batch Packaging Records, while performing gap analysis through document reviews from QC, QA, production, and engineering departments.
∎ Demonstrate a deep understanding of various regulatory guidelines such as ICH, WHO TRS, and PICS, among others
Compensation & Other Benefits:
∎ Mobile bill
∎ Profit share
∎ Provident fund
∎ Weekly 2 holidays
∎ Gratuity
∎ Lunch Facilities: Partially Subsidize
∎ Salary Review: Yearly
∎ Festival Bonus: 2 (Yearly)
∎ Group Life Insurance
∎ Mobile bill
∎ Profit share
∎ Provident fund
∎ Weekly 2 holidays
∎ Gratuity
∎ Lunch Facilities: Partially Subsidize
∎ Salary Review: Yearly
∎ Festival Bonus: 2 (Yearly)
∎ Group Life Insurance
Workplace:
∎ Work at office
Employment Status: Full Time
Gender:
∎ Only Male
Job Location: Narayanganj (Rupganj)
Company Information:
∎ A Listed Reputed Pharmaceuticals Company
Read Before Apply: Please apply only who are fulfilling all the requirements of this job
Application Deadline: 10 Jul 2024
Category: Medical/Pharma
