Mizan Bhuiyan

Report to General Manager, Commercial. Being the regulatory personnel for Renata Limited, the professionalism in the position has conducted through following specific regulatory responsibilities:

Additional Manager, Commercial & Regulatory Affairs - Renata Limited (It was formerly known as Pfizer Laboratories USA.) - Corporate Office: Plot-1, Milk Vita Road, Section-7, Mirpur, Dhaka-1216

(2012-01)

Report to General Manager, Commercial. Being the regulatory personnel for Renata Limited, the professionalism in the position has conducted through following specific regulatory responsibilities:

• Ensuring Compliance with regulations set by the local regulatory authority (DGDA)
• Preparing, compiling & Reviewing Registration documents.
• Communicating with authorities & updating the status of product registration, renewal and price approval.
• Reviewing the common technical documents (CTD) provided by the QC, QAD SPD and R&D departments for registration
• Handling queries raised by regulatory authority during by the evaluation of technical data
• Coordinating concerned (PD, QA, QC, Production, Marketing, SCM) departments in the process of pre-registration, registration, amendment, sample for DTL testing, approval of price and renewal of registration of all products
• Interacting with various administrative, legal & factory departments to collect documents required for regulatory compilation on time
• Ensuring manufactured products are appropriately licensed, produced and marketed with the regulation of Directorate General of Drug Administration (DGDA) Bangladesh
• Undertaking and managing regulatory inspection, escorting government inspectors during inspection and providing post-inspection follow-up information as requested
• Recommending changes to company procedures in response to changes in regulation or standards
• Coordinate recall or market withdrawal activities as necessary
• Reviewing and following up on adverse drug reaction reports submitted to DGDA and attend meetings of DGDA regarding pharmacovigilance as a core member of the PV team of Renata Limited
• Updating FDA, WHO warning and precaution on insert
• Liasson with DGDA in terms of all PV-related activity with DGDA
• Play a role of PV salesforce training
• Liaising with regulatory authorities
• Conducting activity of project approval from BIDA/DGDA
• Handling and coordinating all activities related to the Department of Narcotics (DNC), Department of Explosives, Department of Environment (DoE), Bangladesh Energy Regulatory Commission (BERC), Ministry of Commerce, Ministry of Home Affairs and others
• Handling and coordinating the registration of special products (Biosimilar) and medical devices from DGDA
• Block list preparation and Approval from DGDA
• Price amendment and NOC (Finished Products & CRS sample/) approval from DGDA
• Organize the recipe, inclusion, price, MA of upcoming new products submits the same to Drug Administration (DA) and arrange the approval from DGDA for increasing market share.
• LC, Drugs Clearance, checkup and register maintaining
• Renewal of narcotics license within specified period from Department of Narcotics Control (DNC).
• Obtaining permission to import narcotics raw materials. Unwrapping of imported narcotics raw materials within a short period of time. Approval of new narcotics raw material license and increase of raw material quota as per management requirement.
• INN, BP and USP sample tests from Drug Testing Laboratories (DTL) and sterol and bacterial tests from National Control Laboratories (NCL) are pre-conditions for new product registration.
• Renewal of fish feed import license, fish feed production and processing license and fish feed supply license from the Department of Fisheries (DOF) within specified period. Acceptance of No Objection Certificate (NOC) for import of raw materials for fish feed production. Obtaining permission for unwrapping of imported fish feed raw materials.
• Renewal of 1st class petroleum import and stock license within specified period from Department of Explosives (DOE). Obtaining No-objection certificate (NOC) for import/Export of all types of cylinders and import of all raw materials under the jurisdiction of said Department.
• Renewal of white soft paraffin & heavy liquid paraffin import and stock license from Bangladesh Energy Regulatory Commission (BERC) within a short period of time.
• Trade License approval & renewal
• Environment License renewal and ETP related all works
• BERC license approval and renewal and his raw materials import permission
• Like – Liquid Paraffin, Acetone and all Alcoholic Substances.
• Explosive dept. related all works (Chemical Import License. -M Form, L-Form, Gas Cylinder Storage License approval and IPA, Cylinder gas Import Processing)
• IRC & ERC related all works (license approval & renewal, BIDA Authorization and CCE & E approved permission) Total-07(Seven) License’s
• Herbal Products and IRC related all works (Project Registration & Recommendation from BIDA and IRC approval from CCI &E)
• Upcoming new project for BIDA Registration, BIDA IRC Re-Commendation and CCI & E approval
• All other tasks assigned by the Head of Division which are overall helpful in achieving the goals and objectives of the company.

District Sales Manager - Renata Limited (It was formerly known as Pfizer Laboratories USA.) - Plot-1, Milk Vita Road, Section-7, Mirpur, Dhaka-1216

(2008-01 - 2011-12)

Department: Marketing & Sales

• Developing and expanding territory through generating the doctor Rx share and exceeding sales quantity.
• Stimulating market growth throughout prospecting, supervising, manage and inspire/motive the team members so as to achieve sales target.

Professional Service Manager - Renata Limited

(2007-01 - 2008-12)

• Supporting employee sales and service activity to generate profitable premium growth and market share
• Analyzing local market trends and competitive actions to develop strategic plans to grow sales volume and market share.
• Preparing for and attending assigned state territory conventions, sales & marketing meetings, training meetings, and national state shows.

Professional Service Officer & Senior Professional Service Officer - Renata Limited

(1998-08 - 2006-12)

• Product Development
• Product Launch
• Team Building
• Contract Negotiations

Master of Science (MSc) - Chemistry (Organic) - University of Chittagong