Global Regulatory Affairs Registration Specialist
* Requisition ID: WD170822
* Position: Full-Time Regular
* Open date: Jul 12, 2018 1:39 PM
* Functional area: Regulatory
* Required degrees: Not Indicated
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- Under supervision of the line management, the Registration Specialist will manage GSK Vaccine'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 Chain, QA, QC etc.), Local Operating Companies (LOC's) and regulatory authorities.
- Represents RA in multidisciplinary teams
- Defends regulatory position in front of the different teams and committees
- Negotiation with data generating unit management to ensure that data for files are generated on time for regulatory submissions
- Participates in the definition of regulatory filing strategy and gets involved in interactions with regulatory authorities.
- Participates and provides input in exchange forums in order to support other Global Regulatory teams such as the Regional and Cross-product functional teams.
- Be responsible for Vaccine Registration activities of one or several projects related to cross-products activities in EU and RoW region
- Coordinates all the registration activities for the projects within area of responsibility
- Works to the agreed strategy and actively takes steps to ensure the deadlines are met.
- Communicates with external regulators on specific enquiries
- Main point of contact with the LOC's to ensure shared objectives are achieved
- Contributes to the development of the SOPs and guidelines.
- Participates in the Regulatory Project Team meetings and gives feedback on their specific areas of expertise
Why You?Basic qualifications:
- Master's degree in a scientific domain (e.g. Biology, Chemistry, Pharmacy, Biochemistry, Medical Sciences, Immunology, Analytical Methods etc)
- Minimum 3 years' experience in a Regulatory Affairs function in the pharmaceutical industry or research organization
- Business level English, both written and spoken
- Good understanding of Global Regulatory requirements particularly relating to administrative and procedural aspects.
- Strong interpersonal and influencing skills
- Highly organized
- Ability to manage multiple tasks in a time-efficient manner
- Very clear communication skills (including presentation and negotiations)
- Ability to drive projects in a complex matrix environment with internal GSK stakeholders (Production, QC, R&D)
- High sense of diplomacy to manage relationships with external non-GSK stakeholders (i.e. Regulatory Authorities)
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.
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.
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.