This position is responsible for working with all relevant stakeholders (Govt., Private, International / Local Donor Agencies etc.), developing relationships with KOLs and NGOs to improve patient access to diagnostics.
Ensure close liaison with MSA for KOL engagement.
Responsible for all local regulatory issues, including compliance with regulatory requirements for product registration and GDPMD certification as per the requirement of DRAP (Drug Regulatory Authority of Pakistan)
Job Accountabilities:Access:
Enable Access for patients to Roche?s innovative solutions.
Establish and maintain excellent relationships with all relevant stakeholders to shape the external environment.
Collaborate with MSA to identify and engage KOLs.
Develop relationships with the patients associations and NGOs working in the healthcare sector.
Work with private insurance & innovation initiatives to create new access solutions which enable more patients to benefit from Roche solutions.
Collaborate internally and with Pharma & DC colleagues on the OneRoche approach.
Regulatory:
Prepare, and submit registration dossiers for medical devices registration in the required format. Follow-up input request from Drug Regulatory Authority of Pakistan to ensure successful product registration.
Submit supplementary for approved products when there is an update of the dossier.
Ensure local regulations are observed and implemented within the company.
Coordinate with global regulatory and DRAP for all regulatory-related issues.
Assist in preparing the GDPMDS (Good Distribution Practice for Medical Devices) audit.
Maintain the PMDR (Pakistan Medical Device Register) Listing for approved products.
Maintain the registration status in SAP. Prepare / update Quality & Regulatory SOPs.
Additional Responsibilities:
Attend/complete all requisite online and F2F training (Role-specific, Safety Responsibility, and Compliance) within the specified time limit.
Identifies, collects, and immediately reports all safety-related information on Roche products to Local Safety Responsible as per Roche requirements and local regulations.
Comply with all applicable guidelines of Symphony, compliance, and PRI/PSI.
Eligibility:
Bachelor?s degree in Pharm-D / Science / Business.
Master?s degree in Business (MBA preferred).
5 years? experience in diagnostics / 2 years experience in access function.
A proven track record in developing and managing strategic relationships with internal/external stakeholders.
Strong communication skills (written, verbal, and presentation) - sales experience could be good..
Solution-oriented and able to perform analysis for decision making.
Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we?ve become one of the world?s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche is an Equal Opportunity Employer.
