Executive, International Regulatory Affairs

Job Description

Title: Executive, International Regulatory Affairs

Company Name: Popular Pharmaceuticals PLC.

Vacancy: --

Age: At most 32 years

Job Location: Gazipur (Tongi)

Salary: --

Experience:

• At least 2 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• M. Pharm/B. Pharm from any reputed university with excellent academic records.

• At least 2 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• 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.

• 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 9000 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.

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