Regulatory Affairs and Safety Associate

Opportunity Information

The Role

Reckitt is hiring a Regulatory Affairs and Safety Associate in Islamabad, reporting to the Regulatory & Medical Affairs Manager, responsible for regulatory and government affairs including NDA submissions, variations, renewals, regulatory intelligence and CARA.

•Handle all regulatory and government affairs functions including submissions and acknowledgement of NDA, variations, renewals, regulatory intelligence and CARA •Support the Regulatory Affairs Manager with strategic solutions for business expansion and regulatory compliance •Ensure registration, renewals and legal compliance of the company's products and coordinate approval of changes related to products/ manufacturing site •Implement, maintain and update RB Pakistan in accordance with local regulatory legislation, rules and regulations •Collect and collate information and provide strategic inputs to management for timely regulatory decisions •Advise the company on regulatory requirements, review company practices and recommend changes to systems •Prepare and coordinate documentation and liaise with and make presentations to regulatory authorities •Submit licence and clinical trial applications and pharmacovigilance reports to authorities as per timelines •Manage registration-related activities and negotiate with regulatory authorities for product registration and price fixation/ reviews •Visit PSQCA quarterly for renewals and PFA quarterly for food product registration •Upload all regulated and non-regulated products on CARA and maintain local regulatory intelligence updates in the RB system •Assist the RAM in issues related to other government departments, ministries and divisions

Applicants General Eligibility & Requirements

Education, Experience and Skills Requirements

Salary, Compensation & Benefits