Assistant Manager Regulatory Affairs

1 week ago

Lahore, Punjab, Pakistan SERVIER MONDE Full time 1,200,000 - 3,600,000 per year

Elevate Your Career with Servier Pakistan

Activities & Responsibilities:

Drug Regulatory Authority of Pakistan (DRAP)

To develop and maintain close liaison with all offices and branches of Drug Regulatory Authority of Pakistan (DRAP) Islamabad especially with the offices/wings of Controller, Registration, QA/QC, R&D, Licensing, Pricing & Renewals, Pharmacy Services. Ensuring that Company's products comply with the regulations. Collecting information and provide input enabling the management to take timely decisions for regulatory compliance. Preparation of new product registration dossier as per CTD format & timely submission to DRAP. Proficiency in DRAP regulatory submission software (eAPP etc.). Timely submission of variations to registration applications and renewals of registration. Advising company on regulatory requirements, resolving any complex issues, if arise. Submitting license applications to authorities to get approvals as per timelines. To expedite & get positive decisions regarding technical matters/issues with Provincial Quality Control Boards at Sindh, Punjab, Balochistan and Khyber Pakhtunkhwa.

Network Development (Federal as well as Provincial Levels)

Able to develop and maintain strong relations with DRAP, Drugs Control including Drug Testing Labs., Federal Inspectors of Drugs, Provincial Quality Control Boards, Area Assistant Drugs Controller Offices and Ministry Pharmacists. To develop and maintain strong relations with key opinion leaders nominated by DRAP and to be able to get positive remarks in favor of the Company's products.

Regulatory Intelligence/Updates:

To be up to date with the information about New Registration / approval / competitors' approvals / Price fixation / Agenda of meetings / Minutes of meetings / New SROs / Changes in MOH etc. Keep updates and provide information regarding patent development and issues in Pakistan. To maintain effective market intelligence regarding new registrations, launches, and price increase endeavors by the competitors. To be able to get first-hand information regarding any pharmaceutical matter with Ministry of Health, i.e. inside information on different proceedings like meeting agendas, minutes of meetings and follow ups.

Pricing Issues:

Submit the Costing data after receiving from Local Finance, Head Office and coordinate with DRAP Pricing Department. Develop good liaison with the DRAP Price Advisory Committee members to get the price approvals in favor of the company (Hardship cases). Strong liaison with the officers and the related staff of Pricing Department. Negotiating with regulatory authorities for price fixations and reviews.

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.

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