- Entry level
- No Education
- Salary to negotiate
Director Regulatory Affairs, Quality Assurance & Compliance
Regulatory Affairs & Quality Assurance
Position Reports to
Office 70% Field 30%
Responsible to Local Management and PDRA Basel for efficient supervision of Regulatory Affairs Department and to ensure that Roche Pakistan Limited meet the regulatory standards of the company and the local Regulatory Authorities.
Responsible to Local Management for efficient supervision of RPL’s products QC/QA activities, (labelling and compliance) to meet the quality standards of the company and of the Regulatory Authorities. Ensure strict compliance of product related cold chain and cool chain activities.
Responsible to Local Management and to Corporate Safety Health & Environment Protection Department, LS for company’s Safety Health & Environment protection matters concerning Head Office, Diagnostic Office and Distribution Centres at Lahore & Islamabad.
Responsible to optimize patient access and pricing in Pakistan through stakeholder engagement, legislative and policy analysis and advocacy.
Develop and maintain relationship involving negotiation and advocacy with government officials, NGOs, Charitable and Donor Organizations.
This role will be instrumental in overseeing the overall compliance activities through professional, effective & timely collaboration with global & regional compliance teams
Responsible for providing legal advice in (and for ensuring the legal support of) all matters that are relevant to business, such as, for illustration, business development support, project execution, contracts (e.g. distribution, marketing, purchasing, consultancy, employment, etc.), corporate governance, litigation, IP, relations/issues with stakeholders.
Act as the Compliance responsible person for policies, education and monitoring plans in his/her respective Country
Support the countries management team with queries and compliance-related advice
Manage compliance within the countries and coordinate with Regional counterparts
REGULATORY AFFAIRS FUNCTIONS
Handling product Registration & Renewals. Interacting with the DRAP officials and Key Opinion Leaders.
Pursuing issues/ follow up with DRAP concerning SLS permissions.
Liaison/facilitation of inspection by Federal and Provisional Drug Regulatory Authorities.
Preparing Documentation and SOPs.
Implementation of Corporate Regulatory guidelines.
Pursuing issues with the DRAP pertaining to manufacturing site changes, formulation changes, labelling changes and shelf life changes. (TRIC cases)
Liaising with the company legal advisor for pursuing product related legal issues and patient issues.
Communication with PTDR Basel and handling TRIC documentation & responses and CDS.
Liaise, assist and provide necessary support to regulatory authorities for promulgation of Biosimilars approval guidelines.
Coordinate implementation of CDS update with all stake holders; i.e. marketing products and management, Sales, Medical & DRAP.
Coordinate dissemination of DHPC letters DIL letters to stake holders, i.e. Medical, Marketing, Sales, Health Care Professionals and DRAP.
QUALITY ASSURANCE FUNCTIONS
Manage overprinting/hologram pasting and QA release activities on finished products packs in compliance with corporate/local regulatory requirements.
Liaison/facilitations of inspections by Federal/Provincial Regulatory Authorities.
Disseminate information and implementation of corporate Pharma Manufacturing Standards. GWPs, GSPs and GDPs, guidelines, directives, SOPs and documentation.
Handling of complaint management & Deviation Management system in Track Wise.
Review/approve Deviations & investigations report writing.
Conduct Internal Audits of Karachi, Lahore and Islamabad Distribution Centre.
Implement Qualifications/validations & transport validations cold Chain program concerning the products.
Monitor Calibration program of 2-8°C temperature monitoring devices in cold rooms.
Liaison with National Control Laboratory, Islamabad for lot release of biologicals.
Handling of product complaints & investigation report move to QA.
Maintain Site Master File and Quality Manual.
Establish/update Local Directives, Procedures, Handbook and manuals for SHE related documentations.
Data compilation Key Figure reporting for corporate sustainability reporting in SEISMO.
Departmental budgeting for period expenses.
Conducting Risk Analysis and updating
About the company
Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.
The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.