Regulatory Affairs and Safety Associate (Government Regulatory Liaison Manager- Islamabad)

Opportunity Information

The Role

Responsible for all regulatory and government affairs functions at Reckitt Pakistan, including submissions of NDA, variations and renewals, regulatory intelligence and CARA. Reports to the Regulatory & Medical Affairs Manager.

•Implement, maintain, improve and update RB Pakistan regulatory compliance in accordance with local Regulatory Affairs legislation, rules and regulations •Collect and collate information and provide strategic inputs to management for regulatory compliance decisions •Advise the company on regulatory requirements and review company practices •Prepare and coordinate documentation •Liaise with regulatory authorities and make presentations to resolve ongoing issues •Submit license and clinical trial applications to authorities as per timelines •Submit pharmacovigilance reports to the authorities as per their timelines •Manage registration-related activities and negotiate with regulatory authorities for registration of company products and for price fixations and reviews •Visit PSQCA quarterly for renewals and pending issues, and PFA quarterly for food product registration •Upload all regulated and non-regulated products on CARA •Keep local regulatory intelligence updated in the RB system •Assist the Regulatory Affairs Manager in issues related to other government departments, ministries and divisions

Applicants General Eligibility & Requirements

Education, Experience and Skills Requirements