Customers : Internal : All
Internal : All
External : DRAP different departments (starting from the Head of the departments till the admin people) , MoNC, NCLB
Regulatory Manager will be responsible for leading a subset of the Business Unit portfolio of development and marketed products in one or several therapeutic area(s).
Responsible to know, to adhere to and to advise others on Regulatory Authority regulations and guidance
Ensure compliance of all regulatory activities with all applicable laws, regulations, Regulatory Authorities requirements and company procedures.
Provide guidance to various teams and stakeholders across the company organization on regulatory requirements / policies for development and marketed products,
Ensure timely registration of new products to secure patients access to sanofi new innovative drugs
Direct involvement in critical area of governmental affairs to contribute to shaping the future of pharmaceutical industry
Comply with Sanofi guidelines and local laws & regulations.
Duties & Responsibilities
Product Registration : To compile Dossiers (according to local requirement) & prompt submission of registration application in DRAP and follow up to get approval.
Renewals : To prepare renewal applications in coordination with quality operation for timely managing / preparation for submission of files for the renewal of all registered products & import permissions.
Communication with DRAP on varied Regulatory matters :
To prepare applications for changes in packaging material’s design, changes in shelf life of products, exemptions from Drugs Labeling on low volume imported drugs, changes in source of products, company name change, transfer of Registrations, CMC changes, labelling changes, shortages,
discontinuation etc. and many other ongoing related matters
Responding various DRAP queries and show-cause notices regarding Sanofi products with support of other stakeholders such as Quality, Legal, Communications, Supply chain etc. as required.
Communication / Submission to resolve Global Regulatory Affairs (GRA) queries
Co-ordination with Global Regulatory team / local Industrial affair team for arrangement of CTD format dossiers along with supporting documents and samples
Renew Package-insert leaflet text in accordance with latest CCDS / SMPC
Respond to various GRA queries and questions
New Products Launches / LRP / Dashboard : Co-ordinate with Global Product Lead and local NPL / BD and maintain LRP on New Product registration and launches.
Keep the Dashboard up to date with Product Lead.
Regulatory Intelligence : Be updated on all related regulatory policies and procedures as per the Drugs Act 1976, DRAP Act 2012 and subsequent notifications announced or drafted.
Regulatory Projects : To provide regulatory support on the assigned projects as and when needed.
Lot Release of Biological Products : Submission and Preparation of Lot Release application for vaccines and biologicals
Hardship Cases : Preparation, submission and follow up of pricing files internally and externally as per local processes
Narcotics Quota : Preparation, submission & follow up for approval of quota application for Narcotic products
Liaise with the key people in DRAP : Visiting DRAP Islamabad quarterly or on need basis to follow up on different cases
Promotional Material approval : Provide regulatory support for promotional, advertising & labelling materials activities by managing the review to ensure full compliance with local regulations & company polices in a manner that enhances business objectives.
Compliance : Work in compliance with Sanofi Quality Documents (QDs)
Accountable for keeping the databases updated on a timely basis for portfolio he / she is in charge of
Management of Regulatory System (SHARE, MisAMM, & RWS) and to keep the online repository up to date
Key shared accountabilities :
Working closely with Pharmacovigilance & Medical to ensure timely submissions & follow up on products alerts & periodic reports
Carrying the planned Activities and reflecting the approvals on the internal systems
Work closely with supply chain and IA to ensure labeling implementation
Knowledge, Skills & Competencies / Language
Excellent understanding of the pharmaceutical industry, drug development environment, and company processes and objectives
Comprehensive knowledge of regulatory requirements, DRAP regulations & guidelines.
Ability to communicate effectively and efficiently with other functional departments in the business and with Health Authorities
Good organizational skills and ability to manage a large workload under pressure and to cope with tight deadlines.
Ability to foresee and respond to potential problems and opportunities.
Ability to quickly gain required therapeutic / product knowledge
Ability to act as a Business Partner.
Awareness and adherence to company internal SOPs & compliance standards
Promptness in respond to authorities requirements and prompt in deliverables
Problem solving skills
An understanding and appreciation of relevant legal, scientific and manufacturing area
Ability to work cross functional to resolve complex issues.
Desire to work as part of an effective, cohesive group.
Education : A scientific or technical degree is preferred
Work experience : Minimum 6-8 years’ experience in similar position, preferably in multinational organization
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health.
We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-
term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life