Assistant Regulatory Affairs Manager

Job description

·  Job facts

Title:

Assistant Regulatory Affairs Manager

Division:

Regulatory Affairs

Qualification : D-Pharm

Masters in Biology /Biochemistry is preferable

Experience: 1-2 years of Sales / Regulatory experience is mandatory

Job Responsibility:

- Liaison with Drug Regulatory Authorities: Ensure to maintain liaison with officials of Drug Regulatory Authority of Pakistan and Key Opinion Leaders.

-Registration of Drugs: Ensure timely submission of new products' registration Dossiers and regular follow-up for registration of products. Timely submission of Drug registration renewal cases to avoid any emergency situation.

-Technical Opinion: Ensure to advise and give technical opinion keeping in view Drug Act policies during preparation of Registration Dossier, Price Fixation of new Registrations, Applications seeking price changes, pursuing issues / follow up with Authorities concerning, Post Approval Changes.

-Safety Reports: Responsible for submission of individual case safety reports to DRAP in collaboration with local safety responsible.

-PAPMD Permissions: Responsible for pursuing issues/ follow ups with Regulatory Authorities of Pakistan concerning PAPMD (Pre Approval Pre Marketing Distribution) permissions.

-Lot Release Requests: Ensure timely submission and regular follow up for earliest lot release requests.

-Information Sharing: Responsible to gather, evaluate and share useful information with higher authorities particularly information about competitors' Activities regarding product registration, pricing etc.

-Approval of Post variation changes of Registered products: Responsible for timely submission of documents for approval of post variation changes. Vigorous follow up for timely approval in order to avoid any delay in stock because of delay in approvals.

-Facilitate Inspection by Federal Drug Regulatory Authorities: Responsible to facilitate inspection if planned by Federal Drug Regulatory Authority.

Regulatory Compliance:

·  Develop and maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards
·  Support regulatory inspection-readiness for the Affiliate, including leading or participating in internal/external regulatory audits.
·  Ensure assigned Affiliate regulatory activities comply with Roche global standards and local regulations

·  Who we are

At Roche, 94,000 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.