Informs management on regulatory activities impacting s-a business Provides and implement action plans for shaping the future regulatory environment Ensures enhancement of regulatory expertise and knowledge sharing Sets up and leverage external information network to identify and understand emerging agency policies and provide guidance on agency guidelines Represents sanofi-
aventis on relevant industry association committees Job Family Group : Regulatory Affairs - Intelligence & Policy
Customers : Internal : All
Internal : All
External : DRAP different departments (starting from the Head of the departments till the admin people) , MoNC ,NCLB
Duties & Responsibilities
Act as an interface between Sanofi Pakistan & DRAP, MoNC & NCLB officials
Regulatory & competitive Intelligence
Discussions with DRAP, MoNC & NCLB officials for each case in details
Rigorous follow up to receive Registration of new products and / or presentations and renewal of existing ones and pricing new products, hardship cases, quota approvals, variations etc.
Direct involvement in critical area of governmental affairs to contribute to shaping the future of pharmaceutical industry
Collection of information required for submission for new registration, license renewal & periodic update to Regulatory Authorities.
Following and complying with all the defined internal policies and procedures of working
Experience & Knowledge :
Proven track record of managing & resolving complex cases with DRAP, MoNC & NCLB
Minimum 6-8 years’ experience in similar position, preferably in multinational organization
Comprehensive knowledge of regulatory requirements, DRAP, MoNC & NCLB regulations & guidelines.
Excellent communication / networking, negotiation and presentation skills, both verbal and written with DRAP, MoNC & NCLB officials
Demonstrates ability to manage multiple & complex assignments.
Strong interpersonal skills to deal with sensitive and occasionally contentious issues.
Innovative with the ability to coordinate and drive a complex and changing environment
Awareness and adherence to SOPs & compliance standards
Promptness in responding to drug regulatory authority requirements and prompt in deliverables
Resilience to stress (work in urgency), rigor, reliability and discretion
Capability to deal with a vast number of information and prioritize according to business relevance
Assertive, Objective-oriented & Innovative
Have basic knowledge of MS office
Education : A scientific or technical degree is preferred
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.