Assistant Manager, International Regulatory Affairs

Job Description

Title: Assistant Manager, International Regulatory Affairs

Company Name: Popular Pharmaceuticals PLC.

Vacancy: --

Age: At most 40 years

Job Location: Gazipur (Tongi)

Salary: --

Experience:

• At least 8 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. MBA in Marketing will be an added advantage

• At least 8 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Age At most 40 years

• Strong understanding of international regulatory guidelines (e.g., FDA, EMA, ICH, WHO).

• Expertise in regulatory submission processes, including eCTD preparation and management.

• Strong communication and interpersonal skills for effective collaboration and negotiation.

• Proficiency in regulatory software and document management systems.

• Highly detail-oriented with exceptional analytical skills.

• 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

• Develop and execute regulatory strategies for product registration, renewal, and variations in international markets.

• Evaluate regulatory requirements of target countries and ensure timely compliance to support market expansion.

• Prepare, review, and manage the submission of regulatory dossiers for new product registrations, license renewals, and post-approval changes in alignment with international standards.

• Ensure submissions are accurate, complete, and in compliance with guidelines such as ICH, WHO, FDA, EMA, and other regulatory agencies.

• Monitor changes in international regulatory frameworks and provide guidance to internal teams on necessary adjustments.

• Conduct gap analyses and risk assessments to identify compliance issues and implement corrective actions.

• Work closely with R&D, Quality Assurance, Production, and Supply Chain teams to obtain and verify data required for regulatory submissions.

• Provide regulatory expertise to ensure product development aligns with international requirements.

Salary

• Attractive compensation package will be offered to deserving candidates

Compensation & other benefits

• Provident Fund

• Gratuity

• Festival Bonus : 3 (Yearly)

• Leave Fare Assistance

• Soft Furnishing Allowance

• Mobile Phone Allowance (MSA)

• Profit Bonus

• Medical Facility

• Earn Leave Encashment

• Group Life Insurance

• Subsidized Lunch Facility

• Pick & Drop Facility

• Weekly Holiday : 2 days