Regulatory Affairs Cluster Lead
GSK
Moscow, Russian Federation
10 дней назад

Your Responsibilities : Job purpose :

Job purpose :

Lead and manage the GSK Regulatory Affairs function regarding both the strategic direction and execution of regulatory affairs activities in EEU* countries and Mongolia, Tajikistan and Turkmenistan (if applicable) to achieve timely registration of pharma and vaccine products, maintain existing licenses and influence / shape the regulatory environment through effective interfacing with regulatory bodies across the Area.

Establish GSK as the leader in the industry for regulatory affairs in terms of the highest standards and pace setting strategies.

Basic qualifications :

  • A degree in a scientific discipline, preferably in a life science (e.g. Pharmacy Degree) and 5+ years of relevant industry experience (including experience at a senior level).
  • First class written and oral communication English language skills.
  • Lead time reduction for regulatory approvals. Ensure the preparation of regulatory strategies and their implemented thereby achieving product registrations within agreed deadlines at the country level.
  • Integration of area, global and regional regulatory strategies. Provide regulatory input into commercial plans. Maximise the value of local clinical trials by utilising them to help drive faster regulatory approvals.
  • Compliance with all Corporate, R&D and national legal & regulatory requirements thereby protecting the reputation of GSK and assuring the safety of the patient
  • Strong and sustainable relationships with internal and external stakeholders across the region region, Biologicals Regulatory Affairs and GRA staff and governmental regulatory bodies.
  • Effective leadership of external activities in regulatory affairs strategies.
  • Proactively identify opportunities and risks to the business in New Product Introduction (NPI), Line Extension, Market Access and Health Technology Assessment (HTA), Tender Projects etc.
  • through use of regulatory expertise and information (product knowledge, technical expertise, regulatory intelligence)

    Preferred qualifications :

  • Effective matrix working within country, Region, Area, International and global environments. Close interactions with Clinical / Medical, Supply Chain HUB, Commercial and Manufacturing functions.
  • High level of influence on Regulatory Affairs personnel.
  • Maintain strong working relationships and positively inform and influence headquarters RA and development personnel.
  • High level of influencing skills required with regulatory bodies & authorities, trade associations and other pharmaceutical companies in shaping the regulatory environment across the Area.
  • Regulatory harmonisation is a slow but ongoing process : lead this activity and ensure that GSK is positioned to comply with both current and future regulatory requirements.

  • Influence Government Affairs strategies and activities that will help drive adoption of rational regulatory processes and speed regulatory harmonization.
  • Why GSK? :

    GlaxoSmithKline (GSK) is a world-leading pharmaceutical company with a mission to improve the quality of human life by enabling people to do more, feel better and live longer.

    We employ 100,000 people in over 115 countries, and our work covers three main areas : Pharmaceuticals, Vaccines and Consumer Healthcare.

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