Officer/Senior Officer, Strategic Regulatory Affairs

Job Description

Title: Officer/Senior Officer, Strategic Regulatory Affairs

Company Name: Renata Limited

Vacancy: 01

Job Location: Dhaka (Mirpur)

Employment Status: Full-time

Educational Requirements:
∎ M. Pharm/B. Pharm from any reputed university

Experience Requirements:
∎ 2 to 3 year(s)

Job Responsibilities:
∎ Preparation of eCTD, Submission of applications to regulatory bodies like- US, EUROPE, and the UK for all necessary approvals
∎ SPL (Structured Product Labeling) preparation in XML language which includes submission of the package insert, Establishment Registration (ER), GDUFA Facility registration, etc. as per FDA requirement
∎ Review documents such as specifications, certificate of analysis, protocol, stability data, Analytical report, Risk Assessment, etc. required for submissions
∎ Coordinating with various departments - R&D, ARD, manufacturing site for collecting and verifying all technical documents
∎ Regular monitoring of different regulatory guidance updates and providing updated regulatory information to respective concerns

Additional Requirements:
∎ Age at most 30 years
∎ Experience in supporting regulatory submissions, queries response in the EU, US, and UK markets. Also, should have knowledge of post-approval activities
∎ Should have understanding in Pharma Formulation development, Method validation/verification, BE study, etc.
∎ Good interpersonal and communication skills
∎ Candidate must possess excellent planning & execution as well as strong quantitative & qualitative analytical skills
∎ Well conversant with MS Office, MS Excel, MS PowerPoint, Acrobat

Salary: Negotiable

Compensation & Other Benefits:
∎ Festival & Annual Bonus
∎ Provident Fund
∎ Gratuity
∎ Group Insurance
∎ Lunch & Transport Facilities
∎ A good & healthy working environment

Job Source: Bdjobs.com Online Job Posting.

Application Deadline: 1 Mar 2022

Company Information:
∎ 22 Feb 2022
∎ Renata Limited
∎ Address : Plot #1, Milk Vita Road, Section-7, Mirpur, Dhaka-1216
∎ Web : www.renata-ltd.com
∎ Business : Renata Limited (formerly Pfizer (Bangladesh) Limited) is one of the leading pharmaceutical companies in Bangladesh. Its vision is to establish itself permanently among the best of innovative branded generic companies.

Category: Medical/Pharma