Sr. Resident Regulatory Manager
Genzyme
Islamabad
25d ago

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
  • Core Competencies

  • 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
  • Risk management
  • Have basic knowledge of MS office
  • Qualification

  • Education : A scientific or technical degree is preferred
  • 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

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