Executive/Sr. Executive, Global Regulatory Affairs

Published On

14 Sep 2023

Company Information

Navana Pharmaceuticals Limited

Address : House # 99, Road # 4, Block # B, Banani, Dhaka -1213

Business : Pharmaceuticals

Executive/Sr. Executive, Global Regulatory Affairs

Navana Pharmaceuticals Limited

Vacancy

Not specific

Job Context

    Navana Pharmaceuticals Ltd. is undergoing major expansion to meet the growing need of domestic as well as export market. Navana is looking for enthusiastic, ambitious and hardworking individual for the following position.

Job Responsibilities

  • 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.


Employment Status

Full-time


Educational Requirements

  • M.Pharm or M.Sc. in Chemistry/Applied Chemistry/Biochemistry.


Additional Requirements

  • Age at most 32 years
  • (3-4) 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.

Job Location

Narayanganj (Rupganj)

Salary

    Negotiable

Compensation & Other Benefits

  • Mobile bill, Profit share, Provident fund, Weekly 2 holidays, Gratuity, Over time allowance
  • Lunch Facilities: Partially Subsidize
  • Salary Review: Yearly
  • Festival Bonus: 2
  • Group Life Insurance


Job Source

Bdjobs.com Online Job Posting.

Published on: 14 Sep 2023

Vacancy: 
Not specific

Employment Status: Full-time

Age: Age at most 32 years

Job Location: Narayanganj (Rupganj)

Salary: Negotiable

Application Deadline: 28 Sep 2023


Applicants are encouraged to submit Video Resume

Read Before Apply

Applicants are encouraged to submit Video Resume.

*Photograph must be enclosed with the resume.

Apply Procedures


Hard Copy

Eligible candidates are invited to apply with a recent passport size photograph, Complete CV, Hand written application, NID copy, All Academic certificates` copies, Experience certificates to HRD of Navana Pharmaceuticals Limited, House # 99, Road # 4, Block # B, Banani, Dhaka-1213 by September 28, 2023.



Application Deadline : 28 Sep 2023

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