GSK is looking for a
Technical Specialist CMC Regulatory Affairs (M/F)
Requisition ID: WD204833
As Specialist, CMC, Global Regulatory Affairs, you will be in charge of the writing and edition of technical regulatory documents (CMC documents). These documents are needed to support development and registration of new vaccines, as well as to ensure maintenance of existing vaccine licenses (life-cycle).
Provide timely quality support to Projects, Regions and Cross-products Function through writing of worldwide technical regulatory documentations:
- Writing and timely delivery of high quality harmonized/standardized ”Right First Time” technical regulatory documents, as agreed with the business partners (Projects, Regions, & Cross-product function).
- Liaising with data generating units within the organization (e.g. GIO, R&D) to ensure adequate receipt of documents in order to write CMC documents of high quality.
- When applicable, review technical documents prepared by Portfolio/Projects: content and QC check.
Internal and external interactions:
- As applicable, provide adequate input into strategic and scientific expertise to development and life-cycle projects, as appropriate.
- In partnership with Portfolio/Projects and Cross-product Function, provide adequate input instrategic and scientific expertise to GSK Vaccine Advisory Bodies, as appropriate.
- In partnership with Portfolio/Projects, Regional RA teams and Cross-product Function, participate in adequate and efficient interactions with regulatory authorities to optimize scientific RA strategy and content of regulatory documents and files.
- Interact appropriately with other RA groups (Facility, Cross-product, Projects, Regions).
- Share technical (CMC) regulatory and knowledge based expertise within the CMC teams.
- Participate in transversal product-related matters, as appropriate.
- Ensure technical file content are prepared in line with high regulatory and scientific standards, and/or templates.
- Master in Sciences or Medical Sciences.
- 3 years + in the pharmaceutical industry or research organization, with demonstrated organizational skills.
- Experience in regulatory affairs and/or scientific writing would be a plus.
- Good writing skills, able to negotiate with individuals at same time as understanding departmental constraints/pressure (act with empathy, build network and goodwill) within a highly complex organization (matrix structure, multi-disciplinary and multi-cultural teams).
- 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.
If you require a reasonable adjustment to the application/selection process to enable you to demonstrate your ability to perform the job requirements you will have the opportunity to let us know what specific assistance you require. This will help us to make suitable arrangements to support you throughout our selection process.
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.
We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
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 emphasize the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.
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.
At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
You may apply for this position online by selecting the Apply now button.
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