Opportunity Information
1
Multinational Corporate Entity/ Company
Leadership
On Site
Karachi
The Role
A Regulatory Manager role acting as the bridge between Reckitt and regulatory agencies in Pakistan, guiding products through regulatory landscapes. The position reports to the Senior Director Regulatory & Medical Affairs AMET, Global QPPV, with a dotted line to the Country General Manager.
•Provide regulatory and product compliance expertise on advertising, label claims, printed packaging and promotional materials •Protect key brand and product claims using regulatory expertise •Provide technical support and advice on consumer and legal inquiries and regulatory issues for products marketed in Pakistan •Advise Legal, Supply, Marketing and Finance on medical and regulatory affairs and product safety •Train employees and contracted services on pharmacovigilance requirements and the sales force on drug safety •Ensure registration and regulatory compliance of marketed products with national requirements •Compile national dossiers and maintain registration, license and regulatory compliance files; submit registration and variation applications •Develop national texts (e.g. PIL, SPC, packaging), including coordination of translations •Coordinate Certificates of Free Sales for export •Maintain a database of local regulatory requirements and monitor local regulatory trends •Collect, assess and report adverse events and adverse drug reactions and fulfil reporting timelines to authorities
Applicants General Eligibility & Requirements
9+ years
Education, Experience and Skills Requirements
- Bachelor 16 Years: Pharmacy, Chemistry, Human Biology, Medicine, Veterinary Science, Biochemistry, Biology
At least 9 years of experience in the OTC market and within an FMCG/ pharmaceutical environment, with experience in regulatory and/ or safety, sales/ trade marketing/ marketing roles; broad knowledge of Pakistan regulatory and healthcare systems
Business Strategy, Regulatory Compliance, Product Lifecycle Management, Change Leadership, Relationship Management
Pharmacist (approbation) or degree in pharmaceutics, chemistry, human biology, human medicine, veterinary medicine, biochemistry or biology
Reckitt Benkiser