Senior Executive, Regulatory Affairs

Job Description

Title: Senior Executive, Regulatory Affairs

Company Name: Synovia Pharma PLC.

Vacancy: --

Age: At least 25 years

Job Location: Dhaka

Salary: --

Experience:

• At least 3 years

• B. Pharm / M. Pharm degree completed from a reputable and recognized university.

• At least 3 years

• Age At least 25 years

Professional Experience:

• A minimum of 3 years of progressive experience within a Regulatory Affairs function at a well-reputed pharmaceutical company operating in Bangladesh.

Technical Competencies:

• Clear, in-depth comprehension of the local pharmaceutical regulatory environment and active compliance frameworks.
• Strong procedural understanding of the workflow, structure, and operational systems of the Directorate General of Drug Administration (DGDA).
• Professional familiarity with key institutional stakeholders and regulatory officials.
• Very good communication skill - verbal and written both in English and Bangla
• Excellent literacy in MS-Office

Job Location: Synovia Pharma PLC. Head Office, Dhaka.

Role Overview:

Synovia Pharma PLC is seeking a dedicated and experienced professional for the position of Senior Executive, Regulatory Affairs. In this role, you will be responsible for managing end-to-end product registration portfolios, ensuring full regulatory compliance with the Directorate General of Drug Administration (DGDA), and executing critical operational tasks to support our manufacturing, commercial, and export operations. You will serve as a vital link between the company and regulatory authorities while collaborating cross-functionally to achieve long-term business objectives.

Key Roles and Responsibilities:

1. Product Registration & Lifecycle Management

• Efficiently compile and submit dossiers to DGDA - Technical Sub-Committee (TSC) and Drug Control Committee (DCC) - for the registration of new brands, line extensions, and product renewals.
• Manage the submission and approval process for recipes, registration/inclusion annexures, and packaging materials. Secure Marketing Authorization (MA) approvals and handle subsequent MA renewals across all product brands.
• Review all packaging texts and artworks in detail to ensure complete correctness and strict alignment with DGDA design and layout guidelines.
• Prepare, submit, and secure approvals for -
  • product amendments,
  • price approvals (for both local and imported formulations), and
  • applications for No Objection Certificates (NOC).

2. Compliance, Licensing & Audits

• Lead the preparation and organization of documents required for the renewal of the company's Manufacturing license and Good Manufacturing Practices (GMP) certification.
• Coordinate, facilitate, and organize official audits and site visits conducted by DGDA officials.
• Assist regulatory officials during inspection processes to finalize audit reports and official visit minutes.
• Track and follow up on the timely completion of Corrective and Preventive Actions (CAPAs) related to license renewals and certification by DGDA.

3. Supply Chain, Commercial Support & Vaccines

• Facilitate timely follow-ups and secure import approvals for APIs, excipients, packaging materials, and finished goods (medicines and vaccines). Oversee the submission and approval pipeline for the Lot Release Certificates (LRC) of all vaccine portfolios.
• Review marketing promotional materials from a regulatory standpoint to verify that all medical claims and information meet DGDA guidelines, ensuring timely submission for official approval.

4. Export Regulatory Operations & Communication

• Manage export-driven regulatory workflows, including the registration of international brand names and obtaining necessary regulatory certificates/docu ments from the DGDA.
• Coordinate the legalization of all required export documentation through relevant foreign embassies.
• Maintain regular internal communication regarding regulatory updates, providing guidance to respective departments to ensure timely compliance and implementation.

5. Cross-Functional Collaboration

• Work as a collaborative team member with Marketing, Medical Affairs, New Product Development, Export, Manufacturing, Quality Control, Supply Chain, Finance, and HR departments to support routine operations and specialized corporate projects.
• Execute additional tasks and strategic assignments as directed by departmental superior and executive management from time to time.

6. Global Principal Relations & Platform Management

• Maintain a well-mannered, professional, and collaborative relationship with the global principal, Sanofi SA, France, particularly with key personnel in the
• global and regional Regulatory Affairs (RA) teams responsible for the Bangladesh market. Effectively comprehend all official communications from the global principal, ensuring accurate, appropriate, and timely responses.
• Execute and complete assigned regulatory tasks and global projects within designated timelines.
• Actively manage and update Sanofi's shared virtual common platform (Veeva Vault) with the latest regulatory data, project statuses, and action records.
• Maintain clear internal visibility by keeping the immediate Line Manager and the Director regularly updated on all global principal communications and project milestones.