Registration Specialist, Cross-Products
GSK
Wavre
17 dagen geleden

Your Responsibilities : Job Purpose :

Job Purpose :

  • Under supervision of his / her line management, the Specialist Registration, Cross-Product, Global Regulatory Affairs will manage Company’s regulatory activities related to cross-
  • product changes, worldwide. The job holder will execute regulatory activities in accordance with the defined strategies and priorities.

    Appropriate preparation, submission and follow-up of the registration files will ensure a successful and timely approval.

    Management of these activities includes efficient communication with internal stakeholders (Supply, QA, QC, ), Local Operating Companies (LOC’s) and occasionally regulatory authorities.

  • The Specialist Regulatory Affairs, will participate and provide input in exchange forum in order to support Projects’ Global Regulatory Lead teams, Regional and Cross-
  • product functional team (e.g. RPTs), represent RA in multidisciplinary teams (e.g. Supply teams), will participate in the definition of regulatory filing strategy and get involved in regulatory authorities’ interactions.

    Key Responsibilities :

    The role has the following responsibilities, under supervision of his / he line management :

  • Be responsible for Vaccine Registration activities of one or several projects related to cross-products
  • Coordinate all the registration activities for the projects within area of responsibility
  • Work to the agreed strategy and actively take steps to ensure the deadlines are met.
  • Communicate occasionally with external regulators on specific enquiries
  • Maintain close contacts with the LOC’s to ensure shared objectives are achieved
  • Exhibit a good understanding of the global regulatory legislation, particularly relating to administrative and procedural aspects.
  • Good understanding of Global Regulatory requirements
  • Participate in the development of the SOPs and guidelines, be trained, be a good relay to develop the awareness within the team, and follow Company procedures appropriately.
  • Participate in the Regulatory Project Team and gives feedback on his / her specific areas of expertise
  • The job holder will also have to frequently deal with multi-cultural responsibilities :

  • The job holder’s working environment is composed of managers / scientist of multiple origins
  • Regulatory files are prepared for and submitted world-wide (US, Canada, EU, Japan, China, Brazil, etc), hence requiring flexibility and adaptations to each country culture, regulations and mindset, which could also include interactions with the multiple different regulatory authorities
  • Regulatory submissions require interactions with GSK world-wide network of local operating units, hence necessitating also adaptations to GSK colleagues cultures and ways of working

    Basic qualifications : Minimum Level of Education :

    Minimum Level of Education :

    Master in Sciences or Medical Sciences (Biology, Chemistry, Biochemistry, Medical Sciences, Engineering, Immunology, analytical methods and tools)

    Preferred Level of Education :

    Engineer or PhD in Life sciences, Pharmacy or equivalent (Biology, Chemistry, Infectious disease, Biochemistry, Medical Sciences, Engineering, Immunology, analytical methods and tools, Regulatory Affairs, Team and People Management experience)

    Minimum Level of Job-Related Experience required :

    3 years + in the pharmaceutical industry or research organization, with demonstrated organizational skills.

    Preferred qualifications :

  • Good interpersonal, communication (including presentation) and influencing skills
  • Fluent in written and oral English
  • Good organizational skills, effective time management, ability to manage multiple tasks
  • Good communication skills, from simple communication to negotiation skills , with internal GSK stakeholders (i.e. Management of Production, QC, R&D), but also when required with external non-
  • GSK stakeholders (i.e. regulatory Authorities)

  • The job holder will need excellent communication skills to interact with both internal GSK stakeholders (i.e. Supply, Production, QC, R&D), but also with external GSK (LOC’s) and occasionally non-
  • GSK stakeholders (i.e. regulatory Authorities). Example of interactions :

    oRespond to administrative and procedural enquiries from external regulators

    oEfficient in house’ GSK influencing to :

    oDefend regulatory position in Company’s Teams and Committees

    oNegotiation with data generating unit Management to ensure that data for files are generated on time for regulatory submissions

    Why GSK? : Our Offer :

    Our Offer :

    At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

    GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish.

    GSK is an equal opportunity employer.

    The Department :

    Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist.

    Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation’s three priority diseases -

    HIV / AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.

    When it comes to developing the vaccines of the future, we’re looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.

    We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus

    Our Company :

    GSK is one of the world’s leading research-based pharmaceutical and healthcare companies is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

    GSK Vaccines is one of the world’s leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development.

    We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world’s countries.

    For further information, please visit www.gsk.com.

  • LI-GSK
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