Job Description
Title: Deputy Manager/Manager - Regulatory Compliance
Company Name: DBL Pharmaceuticals Ltd.
Vacancy: --
Location: Gazipur
Experience:
∎ At least 10 years
∎ The applicants should have experience in the following business area(s):Pharmaceutical/Medicine Companies
Published: 16 Apr 2025
Education:
∎ Master of Pharmacy (M.Pharm) in Pharmacy
Requirements:
Additional Requirements:
∎ Strong decision-making skill with the ability to work collaboratively;
∎ Strong interpersonal skill to deal with internal & external stakeholders.
∎ Strong decision-making skill with the ability to work collaboratively;
∎ Strong interpersonal skill to deal with internal & external stakeholders.
Responsibilities & Context:
∎ Ensure regulatory compliance at the plant site and support corporate regulatory affairs in alignment with DGDA requirements;
∎ Maintain consistency between approved drug documentation and manufacturing processes;
∎ Ensure product compliance with global regulatory standards (US-FDA, EMA, MHRA, etc.);
∎ Prepare and submit regulatory dossiers (eCTD, CTD, ACTD) for international marketing authorizations;
∎ Manage submissions and updates including ANDA, PSUR/PADER, annual reports and GDUFA payments;
∎ Coordinate with CROs, CMOs and regulatory bodies to ensure compliance;
∎ Track application progress and marketing authorizations across regulated and ROW markets;
∎ Coordinate regulatory audits and address audit findings with relevant departments;
∎ Oversee regulatory aspects of contract manufacturing and review related agreements;
∎ Share regulatory updates, prepare/review SOPs and support information flow on ANDA/MAA;
∎ Perform additional tasks as required by the Regulatory Compliance Department.
∎ Ensure regulatory compliance at the plant site and support corporate regulatory affairs in alignment with DGDA requirements;
∎ Maintain consistency between approved drug documentation and manufacturing processes;
∎ Ensure product compliance with global regulatory standards (US-FDA, EMA, MHRA, etc.);
∎ Prepare and submit regulatory dossiers (eCTD, CTD, ACTD) for international marketing authorizations;
∎ Manage submissions and updates including ANDA, PSUR/PADER, annual reports and GDUFA payments;
∎ Coordinate with CROs, CMOs and regulatory bodies to ensure compliance;
∎ Track application progress and marketing authorizations across regulated and ROW markets;
∎ Coordinate regulatory audits and address audit findings with relevant departments;
∎ Oversee regulatory aspects of contract manufacturing and review related agreements;
∎ Share regulatory updates, prepare/review SOPs and support information flow on ANDA/MAA;
∎ Perform additional tasks as required by the Regulatory Compliance Department.
Workplace:
∎ Work at office
Employment Status: Full Time
Job Location: Gazipur
Company Information:
∎ DBL Pharmaceuticals Ltd.
Read Before Apply: Please apply only who are fulfilling all the requirements of this job
Application Deadline: 26 Apr 2025
Category: Others
