Work with Product Development, Quality Assurance, and management to prepare and review international Regulatory submissions, including CE technical files and design dossiers, and other international filings as CTD, ACTD to obtain products registration or marketing clearance.
Obtain timely marketing clearance for all products in parallel International Regulatory Submissions.
Submit documents and timely responses to the queries with international Regulatory bodies.
Provide Regulatory oversight of changes in manufacturing facilities, processes, and procedures, as these changes pertain to international regulations.
Coordination, review, and submission of product labeling for marketing outside Bangladesh.
Routine maintenance of approved files, including coordination and preparation of amendments as necessary.
Review design changes and technical files for updates to documentation.
File Certificates to Foreign Regulatory Authorities.
Develop relevant Regulatory SOPs as necessary.
Ensure conformance to ISO, EMEA, ASEAN, FDA and other international/local regulations.
Understand the company's products, techniques and the use of instrument systems.
Actively participate on cross-functional project teams associated with the technical transfer activities for moving new and existing pharmaceutical products.
Review validation protocols and task reports, ensuring compliance with Standard Operating Procedures during Dossier Review.
Manage multiple projects at multiple sites with limited supervision.
Maintain Standard Operating Procedures and Validation Master Plans ensuring conformance with CGMPs, corporate and regulatory agency guidelines.
Serve on project teams and on cross functional process development teams as necessary.
Maintain a working knowledge of pharmaceutical manufacturing processes, and knowledge of FDA, EU regulations.
Properly document results and assure integrity and accuracy of record keeping and documentation.
Manage the tracking and oversight of the regulatory change management system in association with process changes requiring regulatory approvals.
Work with Production, Procurement, QA and QC on Supplier Qualification and maintenance.
Perform periodic process quality/compliance verification checks.
Work closely with Quality and Regulatory Affairs to assemble and prepare and provide regulatory submission documentation.
Provide back-up support to site quality assurance activities.
Key participant in site Inspection Readiness processes.
M. Pharm from any reputed University.
3 to 4 year(s)
Age 25 to 30 years
3-4 years of experience in the pharmaceutical industry
Communication- Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Writes clearly and informatively; Presents numerical data effectively
Leadership- Exhibits confidence in self and others; Inspires and motivates others to perform well; Accountable for behaviors and their impact on others; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others
Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Adapts strategy to changing conditions. Critically evaluates quality systems to propose best practices.
Computer skills: MS Office (Word, Excel, PowerPoint and Access)