Muhammad Sohail

Experience

• 

  Muller & Phipps Pakistan (Pvt) Ltd

  Nov 2011 - May 2014

  Regulatory Affairs Officer

  Job Description:This position is responsible for the compliance of the Drug Act 1976 & rules framed there under. Maintain all kinds of documentation viz., receiving reports, transfer invoices, warranties, temperature records etc. Foster cordial relationship with the authorities and be informed of the regulatory inspections & developmentsKey Job Responsibilities:-Ensure storage of products according to their temperature control requirements and maintenance of Temperature Log Sheets / data logger on a daily basis and send it to Head Office on a monthly basis for review. Ensure proper warehouse and storage temperatures, as per the products label requirements, through proper arrangements of light, ventilation and humidity.Acquaint with the expiry policies of various Principals for proper process implementation and provide guidance to Warehouse Incharge. Ensure complete documentation and coordinate survey as regards expired stock e.g. Stock adjustment Slip (SAS) in order to maintain accurate stock balances in record and physically at the depot.Check and verify batches of stock against summary (cash memos/ invoices) being delivered to the market & inter depot transfers.Ensure cool chain practices are being followed with respect to handling of heat sensitive products; utilization of icepack; ice coolers / thermo pole boxes during inter depot transfer and distribution.Monitor proper handling, examination, segregation and storage of returned/ unsalable / damaged/ expired stock in the Quarantine area labelled as Stock Not For Sale and accordingly timely disposal of the expired stock. Ensure proper stacking of returned stock and verify it with Cash memos / invoices for products, quantity and batch number on daily basis.Ensure Principals Audit observations are timely addressed.Comply with Drug Sale License requirements and arrange its renewal before expiry date and coordinate with Local Drug Inspectors / Offices. Show less

• 

  CCL Pharmaceuticals

  May 2014 - Sept 2015

  Sr Regulatory Affairs Officer

  To prepare and submit Domestic,import and Export dossiers of DRAP and selected international markets,handle queries and follow up till registration.To prepare and submit dossiers for Alternative Medicines and Health Products according to Alternative Medicines and Health Products (Enlistment) Rules, 2014.To prepare and submit dossiers for Food supplements registration according to guidelines of Cambodia,Kazakhstan,Kyrgyzstan,Uzbekistan.To standardize company/product administrative ,production,quality control,quality assurance and pharmacological data according to ICH guidelines.Prepare and process applications for the issuance of CPP's,NOC's and attestation of documents from LCCI,Foreign office and embassies and handle assigned international regulatory affairs.To do assigned quality control and quality assurance tasks.To handle any other assignment given by Reporting Officer or Manager. Show less

• 

  Fresenius Medical Care Pakistan Pvt Ltd

  Oct 2015 - now

  Responsible for coordination & preparation of regulatory submissions, renewals, design changes and tenders and follow-up on progress. Ensure applications comply with Company’s and national requirements in country. Further to take effective actions to obtain timely product approvals.Responsible for the management of regulatory affairs personnel, train and support regulatory affairs personnel to be competent and accurate in regulatory submissions, renewals, design changes and tenders.Setup & maintain RA systems ensuring the data are kept up to date.Develop and implement SOPs.Write, review & advise on dossiers for new products, including labeling to meet Company’s and national requirements.Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulationsRecognise recurring RA issues, take effective actions and provide solutions.Be part of project team on ad hoc projects, to provide regulatory input and strategies in order to obtain timely regulatory approvals for the products as part of the product development planning.Provide monthly status report on approvals, applications, information on new/draft registration regulations and impact to existing approvals.Act as the primary point of contact for the Health Authority and be actively involved as a Liaison Officer for the Health Authority.Support regulatory activities for business tender participation.Act as country Pharmacovigilance Responsible Person.Act as Management Representative for the implementation of Quality Management System. Show less

  • Manager Quality, Regulatory Affairs & Management Systems (QREM) and Pharmacovigilance

    Aug 2017 - now

  • Assistant Manager Quality, Regulatory Affairs & Management Systems (QREM) and Pharmacovigilance

    Oct 2015 - Aug 2017