Sr. Executive/Executive, International Regulatory Affairs

Job Description

Title: Sr. Executive/Executive, International Regulatory Affairs

Company Name: Popular Pharmaceuticals PLC.

Vacancy: --

Age: at most 32 years

Location: Gazipur (Tongi)

Minimum Salary: Negotiable

Experience:
∎ 3 to 4 years
∎ The applicants should have experience in the following business area(s):Pharmaceutical/Medicine Companies

Published: 6 May 2025

Requirements:

Additional Requirements:
∎ Age at most 32 years
∎ Candidate should be career focused, pro-active, team player
∎ Well proficiency in computer literacy (MS Office)
∎ Basic understanding of international regulatory guidelines (e.g., ICH, FDA, EMA).
∎ Familiarity with regulatory submission processes and documentation requirements.
∎ Strong communication skills to collaborate with cross-functional teams and external stakeholders.
∎ Candidate should be career focused, pro-active, team player
∎ Well proficiency in computer literacy (MS Office)
∎ Basic understanding of international regulatory guidelines (e.g., ICH, FDA, EMA).
∎ Familiarity with regulatory submission processes and documentation requirements.
∎ Strong communication skills to collaborate with cross-functional teams and external stakeholders.

Responsibilities & Context:
∎ Prepare, compile, and review regulatory submissions of CTD/ACTD dossiers for various countries, including Asian, African, CIS, LATAM, and semi-regulated markets.
∎ Review regulatory deficiencies and address queries raised by overseas regulatory agencies in a timely and accurate manner.
∎ Ensure that all documentation meets the specific requirements of health authorities (e.g., FDA, EMA, MHRA, WHO, etc.).
∎ Coordinate with internal departments (e.g., Quality Assurance, R&D, Production) to gather necessary documents and data for submissions.
∎ Liaise with external regulatory agencies, consultants, and partners to address queries and ensure smooth submission processes.
∎ Maintain accurate and up-to-date records of all regulatory submissions, approvals, and correspondences.
∎ Assist in the preparation of responses to queries from international regulatory authorities.
∎ Ensure timely submission of applications and follow-up to obtain regulatory approvals.
∎ Popular Pharmaceuticals PLC. is one of the top leading pharmaceutical companies in Bangladesh having state-of-the art manufacturing plant located in Tongi. Over the past twenty years we are maintaining very high growth rate in the pharmaceutical industry and today we are an organization of about 10,000 employees. Popular Pharmaceuticals PLC. has already won the trust of the physicians and other stakeholders both in home and abroad. We export our medicines to 32 countries around the world.
∎ To continue our success as a leading and innovative pharmaceutical company, we are looking for smart, talented and energetic candidates to join in our winning team.
∎ Key Responsibilities
∎ Prepare, compile, and review regulatory submissions of CTD/ACTD dossiers for various countries, including Asian, African, CIS, LATAM, and semi-regulated markets.
∎ Review regulatory deficiencies and address queries raised by overseas regulatory agencies in a timely and accurate manner.
∎ Ensure that all documentation meets the specific requirements of health authorities (e.g., FDA, EMA, MHRA, WHO, etc.).
∎ Coordinate with internal departments (e.g., Quality Assurance, R&D, Production) to gather necessary documents and data for submissions.
∎ Liaise with external regulatory agencies, consultants, and partners to address queries and ensure smooth submission processes.
∎ Maintain accurate and up-to-date records of all regulatory submissions, approvals, and correspondences.
∎ Assist in the preparation of responses to queries from international regulatory authorities.
∎ Ensure timely submission of applications and follow-up to obtain regulatory approvals.

Skills & Expertise:

Compensation & Other Benefits:
∎ Attractive compensation package will be offered to deserving candidates
∎ Provident Fund
∎ Gratuity
∎ Festival Bonus: 3 (Yearly)
∎ Leave Fare Assistance
∎ Profit Bonus
∎ Earn Leave Encashment
∎ Group Life Insurance
∎ Subsidized Lunch Facility
∎ Pick & Drop Facility
∎ Weekly Holiday: 2
∎ Salary
∎ Attractive compensation package will be offered to deserving candidates
∎ Compensation & other benefits
∎ Provident Fund
∎ Gratuity
∎ Festival Bonus: 3 (Yearly)
∎ Leave Fare Assistance
∎ Profit Bonus
∎ Earn Leave Encashment
∎ Group Life Insurance
∎ Subsidized Lunch Facility
∎ Pick & Drop Facility
∎ Weekly Holiday: 2

Workplace:
∎ Work at office

Employment Status: Full Time

Job Location: Gazipur (Tongi)

Read Before Apply:

If you think you are the right person that we are looking for, please apply through online only. We discourage hard-copy of the CV.

Company Information:
∎ Popular Pharmaceuticals PLC.
∎ Sheltech Panthakunja, 17 Sukrabad, West Panthapath, Dhanmondi, Dhaka
∎ Popular Pharmaceuticals Limited is a company of Popular Group, one of the leading corporate house in private sector health care management in Bangladesh and is engaged in the manufacturing and marketing of high quality pharmaceutical products both at home and abroad. The company was established with the aim to lead the market of Branded Generics in Bangladesh with a portfolio of vital molecules. Popular intends to focus its skills and resources on all major therapeutic areas that represent majority of the burden of disease profiles of Bangladesh. In a very short span of time, Popular has become one of the leading pharmaceutical company among all pharmaceuticals players in Bangladesh.

Address::
∎ Sheltech Panthakunja, 17 Sukrabad, West Panthapath, Dhanmondi, Dhaka
∎ Popular Pharmaceuticals Limited is a company of Popular Group, one of the leading corporate house in private sector health care management in Bangladesh and is engaged in the manufacturing and marketing of high quality pharmaceutical products both at home and abroad. The company was established with the aim to lead the market of Branded Generics in Bangladesh with a portfolio of vital molecules. Popular intends to focus its skills and resources on all major therapeutic areas that represent majority of the burden of disease profiles of Bangladesh. In a very short span of time, Popular has become one of the leading pharmaceutical company among all pharmaceuticals players in Bangladesh.

Application Deadline: 13 May 2025

Category: Others